Devices for bleeding reduction and methods of making and using the same

ABSTRACT

In some embodiments, a system includes an applicator pad, an application device (e.g., a grip), and a reservoir. The grip can be releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis. The reservoir can be configured to contain medication to be released to the wound via the applicator pad.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Application No. 17/522,736,entitled “Devices for Bleeding Reduction and Methods of Making and Usingthe Same,” filed on Nov. 9, 2021, which is a continuation ofInternational PCT Application No. PCT/US2021/053641, entitled “Devicesfor Bleeding Reduction and Methods of Making and Using the Same,” filedon Oct. 5, 2021, which is a continuation-in-part of International PCTApplication No. PCT/US2021/026714, entitled “Devices for BleedingReduction and Methods of Making and Using the Same,” filed on Apr. 9,2021, which claims priority to U.S. Provisional Pat. Application SerialNo. 63/007,543, entitled “Devices for Bleeding Reduction and Methods ofMaking and Using the Same,” filed on Apr. 9, 2020, the disclosure ofeach of which is incorporated by reference herein in its entirety.

International PCT Application No. PCT/US2021/053641 also claims priorityto U.S. Provisional Patent Application Serial No. 63/087,532, entitled“Methods for Self-Treatment or Home Care Provider Treatment of MinorWounds,” filed on Oct. 5, 2020 and U.S. Provisional Pat. ApplicationSerial No. 63/090,768, entitled “Methods for Self-Treatment or CareProvider Treatment of Minor Wounds,” filed on Oct. 13, 2020, thedisclosure of each of which is incorporated by reference herein in itsentirety.

BACKGROUND

Patients with minor injuries seek medical attention at primary careclinics, urgent care centers, and hospital emergency rooms. Many urgentcare centers are not open twenty-four hours per day and seven days perweek (24/7). Rural areas may have limited availability of these urgentcare centers. A common type of visit to a hospital emergency room orurgent care center is a wound requiring cessation of bleeding,especially patients on anticoagulant or antiplatelet medications. As thepopulation ages, more patients require these medications for a varietyof conditions.

Better methods and devices are needed to allow patients, family members,and/or caretakers to safely treat at home, or at the place of theinjury, minor wounds requiring the cessation of bleeding.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used to limit the scope of the claimed subject matter.

Disclosed herein are devices, methods of using devices, and methods ofmaking devices for treatment of bleeding, e.g. from minor wounds. Insome embodiments, a system includes an applicator pad, an applicationdevice (e.g., a grip), and a reservoir. The grip can be releasablycouplable to the applicator pad and configured to dispose the applicatorpad against a wound of a subject such that pressure can be transferredto the wound via the applicator pad to enhance hemostasis. The reservoircan be configured to contain medication to be released to the wound viathe applicator pad.

Additional features, aspects and/or advantages will be recognized andappreciated upon further review of a detailed description of theillustrative embodiments taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a skin portion, showing thestructures of the epidermis, derma, hypodermis, and subcutaneous layer.

FIG. 2 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIG. 3A is a schematic illustration of the bleeding treatment system ofFIG. 3 , with packaging removed from the bleeding treatment device,shown disposed near a wound on the skin of a patient.

FIG. 3B is a schematic illustration of the bleeding treatment device ofFIG. 3A with an optional applicator seal removed, shown with a portionof the bleeding treatment device disposed adjacent to the wound on theskin of the patient.

FIG. 3C is a schematic illustration of the bleeding treatment device ofFIG. 3A with the grip removed.

FIG. 3D is a schematic illustration of the bleeding treatment device ofFIG. 3A, shown separated from the wound of the patient.

FIG. 4 is a flow chart of a method of using the bleeding treatmentsystem of FIGS. 2 and 3A to 3D to treat a wound requiring cessation ofbleeding.

FIG. 5 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIGS. 6A-6C are schematic illustrations of a bleeding treatment system,according to an embodiment.

FIGS. 7A-7D are schematic illustrations of a bleeding treatment system,according to an embodiment, in an initial configuration.

FIGS. 7E-7H are schematic illustrations of a bleeding treatment systemin a wetting configuration.

FIG. 8 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIGS. 9A-9C are schematic illustrations of a bleeding treatment system,according to an embodiment.

FIGS. 10A-10C are schematic illustrations of a bleeding treatmentsystem, according to an embodiment.

FIGS. 11A and 11B are schematic illustrations of a bleeding treatmentsystem, according to an embodiment.

FIG. 12 is a schematic illustration of an applicator pad and a bloodabsorption pad, according to an embodiment.

FIG. 13 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIG. 14 is a flow chart of a method of using a bleeding treatmentsystem, according to an embodiment.

FIGS. 15A-15E are schematic illustrations of a bleeding treatment systemin various stages of use, according to an embodiment.

FIGS. 16A-16C are schematic illustrations of a bleeding treatment systemin a wetting configuration, according to an embodiment.

FIGS. 16D-16F are schematic illustrations of the bleeding treatmentsystem of FIGS. 16A-16C in a separated configuration.

FIGS. 17A and 17B are schematic illustrations of the bleeding treatmentsystem of FIGS. 16A-16C, according to an embodiment.

FIG. 18 is a schematic illustration of a bleeding treatment system ofFIGS. 17A-17B, according to an embodiment.

FIG. 19A is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIG. 19B is a schematic illustration of a portion of the bleedingtreatment system of FIG. 19A.

FIG. 19C is a schematic illustration of a portion of the bleedingtreatment system of FIG. 19A, according to an embodiment.

FIG. 20 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIG. 21 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIGS. 22A and 22B are schematic illustrations of cross-sectional and topviews of a bleeding treatment system, according to an embodiment.

FIGS. 23A-C are schematic illustrations of a bleeding treatment system,according to an embodiment.

FIG. 24 is a schematic illustration of a bleeding treatment system,according to an embodiment.

FIGS. 25A-25C are schematic illustrations of a sequence of stepsperformed using a kit, according to an embodiment.

FIGS. 26A-26C are schematic illustrations of a sequence of stepsperformed using a kit, according to an embodiment.

DETAILED DESCRIPTION

The detailed description herein serves to describe non-limitingembodiments or examples involving various inventive concepts and usesreference numbers for ease of understanding these examples. Commonreference numbers between the figures refer to common features andstructure having the same or similar functions, as will be understood.While various figures will have common reference numbers referring tosuch common features and structure, for purposes of conciseness, laterfigure descriptions will not necessarily repeat a discussion of thesefeatures and structure.

For reference, FIG. 1 illustrates a cross-sectional view of a skinportion SK of a human, e.g., of a subject to be treated. The skinportion SK includes an epidermis E, a derma D, a hypodermis H, and asubcutaneous layer S.

The systems and methods described herein can be configured to treat awound and/or assist with cessation of bleeding of a wound that extendsthrough the epidermal and/or dermal layer, is non-arterial, is notresulting in pulsatile bleeding, and has no subcutaneous fat or muscleexposed. In some embodiments, the systems and methods described hereincan be self-administered (e.g., the administrator of the system and/ormethod is also the subject having the wound). In some embodiments, thesystems and methods described herein can be administered to a subjecthaving a wound by a person other than the subject, such as a caregiver(e.g., a non-medical home care provider such as a family member) orclinician. In some embodiments, the systems and methods described hereincan be administered to a non-human patient such as a pet dog or a petcat, and the method steps can be performed by a pet owner orveterinarian. In some embodiments, target wounds treatable by thesystems and methods described herein may be less than 3 centimeters inlength. In some embodiments, target wounds treatable by the systems andmethods described herein in a home use setting may be wounds notrequiring stitches or sutures to close. In some embodiments, targetwounds treatable by the systems and methods described herein in aclinical setting may be wounds for which bleeding can first be attemptedto be stopped using the systems and methods described herein beforeutilizing stitches or sutures if the systems and/or methods describedherein are not effective after one use.

Potential patient populations that can be treated by the systems andmethods described herein include any person with topical bleeds (i.e.,bleeding from the skin). For example, target patient populations caninclude people with naturally-induced, drug-induced, orprocedurally-induced increased susceptibility to bleeding and/orresistance to blood clotting. Naturally-induced susceptibility tobleeding and/or resistance to blood clotting can arise from a chroniccondition such as hemophilia, Von Willebrand disease, vascular disorders(e.g., Osler-Weber-Rendu), coagulopathies, kidney failure, liverfailure, bone marrow suppression (pathologically or medication-induced)platelet disorders, age (older people can have more friable skin), orconditions (e.g., a genetic condition) that render the person moreaccident prone or difficult to treat (including age and/or motor orcognitive deficits). Drugs that can induce susceptibility to bleedingand/or resistance to clotting can include: anticoagulation medicationssuch as warfarin, heparin, factor Xa inhibitor, thrombin inhibitors,low-molecular weight heparin, dabigatran, argatorban, hirudin,rivaroxaban, apixaban, edoxaban, fondaparinux, enoxaparin, dalteparin,and bivalirudin; and antiplatelet medications such as plateletaggregation inhibitors such as aspirin (acetylsalicylic acid or ASA),cangrelor, ticagrelor, lopidogrel, prasugrel, cilostazol, clopidogrel,dipyridamole, ticlopidine, glycoprotein platelet inhibitors such asepifibatide, tirofiban, abciximab, and protease-activated receptor-1antagonists such as vorapaxar. Anticoagulation medications can be takenfor a wide variety of indications, such as deep venous thrombosis,pulmonary embolus, and atrial fibrillation. Medical procedures that caninduce susceptibility to bleeding and/or resistance to clotting caninclude renal replacement therapy (e.g., hemodialysis), cardiopulmonarybypass, extra-corporeal membrane oxygenation (ECMO), chemicalthrombolysis (with tissue plasminogen activating factor (TPA)), cardiaccatheterization, peripheral vascular procedures (e.g., femoral-poplitealbypass, arterial thrombectomy), mechanical thrombectomy, angiography,and other neuro-interventional procedures and interventions.

A bleeding treatment system 100 that can be used to treat a woundrequiring cessation of bleeding is illustrated schematically in FIG. 2 .As shown in FIG. 2 , the bleeding treatment system 100 includes anapplicator pad 110, an optional applicator seal 120 coupled to theapplicator pad 110, an optional blood absorption pad 130 coupled to theapplicator pad 110, one or more optional reservoirs 150 fluidicallycoupled to the applicator pad 110 via a fluid coupling 155 andcontaining one or more medications, an applicator device 170 releasablycouplable to the applicator pad 110 and including a grip 140, anoptional release mechanism 160 coupled to the reservoir 150, the fluidcoupling 155, and the grip 140, an optional pad retainer 135 coupled tothe applicator pad 110, an optional user guide 190 associated with theapplicator device 170, and optional packaging 195 to contain the othercomponents of the bleeding treatment system 100. The grip 140 can bereleasably couplable to the applicator pad 110 via an optional padconnector 148.

The applicator pad 110 (also referred to as a topical applicator pad) issized, configured, and formed of material, suitable for covering a woundtreatable by the system 100. The applicator pad 110 may be formed of anyone or more materials having suitable physical properties. For example,the material is preferably capable of absorbing blood. The material mayalso swell or expand upon absorbing fluid such as blood. The materialmay also be capable of containing, absorbing, wicking, or otherwisetransporting one or more medications for application to a surface of thewound WD and/or the skin SK surrounding the wound. It should bebiologically compatible with the skin SK and wound WD. Preferably theone or more materials are also non-reactive, or otherwise compatiblewith any medication(s) to be transported by the applicator pad 110,e.g., not alter the composition, delivery, or efficacy of themedication(s) or degrade or otherwise lose any of its desired physicalproperties upon exposure to the medication(s) over the maximum durationof the wound treatment. The material is preferably sufficiently stiff,resilient, etc. to be capable of applying a sufficient amount ofpressure against the wound treatment to aid in achieving hemostasis,i.e., function as a hemostat. At least a bottom or distal surface of theapplicator pad 110 (e.g., any surface exposed prior to use of thebleeding treatment system 100) can be covered or enclosed by theremovable applicator seal 120 to prevent contamination of the applicatorpad 110 and/or prevent undesired release of any medication(s) that maybe contained in the applicator pad 110. The applicator pad 110 can beformed of a sponge material. The applicator seal 120 can be formed as afilm or other thin layer of material non-reactive with the applicatorpad 110. The applicator seal 120 can be removed from the applicator pad110 prior to use (e.g., via peeling).

Suitable materials for the applicator pad 110 include polymers or othercompositions, such as polyvinyl alcohol (PVA), polyurethane (hydrophilicor otherwise), polypropylene, which may be formed into foams (open orclosed cell) (e.g., a porous expandable foam), natural fibers such ascotton, linen, wool, etc. in woven or non-woven (e.g. felt) form, and/orlayered matrices of foam and/or gauze packing. The applicator pad 110may be formed monolithically of a single material, or may be formed as acomposite or other aggregation of different materials. For example, theapplicator pad 110 may be primarily formed of one material, and have arelatively thin covering of a second material. The materials may achievethe desired functions in different ways. For example, absorption ofblood may be achieved mechanically, e.g. by capillary wicking, and/orchemically, such as by absorption into, for example, molecular sieves orother desiccants, or combination with materials such as clays, e.g.kaolin, bentonite, montmorillonite, saponite, polygorskite, attapulgite,and/or sepiolite. In some embodiments, clay may be dispersed in a liquidmedium. In some embodiments, the applicator pad 110 can include ahemostatic patch and a flexible insulating or wicking mechanism (alsoreferred to as a backing portion or layer). In some embodiments, thehemostatic patch can include liquid medication, and the flexibleinsulating or wicking mechanism can isolate a hand applying pressure tothe applicator pad 110 from the wound site and the liquid medication.

As explained in more detail below, the applicator pad 110 may include,incorporate, or embody a reservoir for medication(s), and a differentmaterial may be used to form or bound such a reservoir. In someembodiments, the applicator pad 110 can include a reservoir for dry orlipophilized medication that may be made flowable via fluid releasedfrom a reservoir of the applicator device 170 and/or blood from thewound. In some embodiments, the applicator pad 110 can define or includeinternal structures or passages to aid flow of medication through theapplicator pad 110 and/or preferentially direct flow toward target woundtissue. In some embodiments, the applicator pad 110 can include acolored dye.

The bleeding treatment system 100 is preferably configured to deliverone or more medications to target wound tissue during treatment, e.g.via the applicator pad 110. The medication(s) may be contained in one ormore reservoirs 150 (which, as noted above, may be separate from orincorporated into the applicator pad 110), may be selectively releasedfrom the reservoir(s) 150 by one or more release mechanisms 160, and maybe conveyed from the reservoir(s) 150 to the applicator pad 110 by oneor more fluid couplings 155. For example, the reservoir 150 may beimplemented as a container (ampoule or the like) having a volumesufficient to contain a therapeutically effective amount of themedication and formed of material impermeable to, and non-reactive with,the medication or its constituents, such as glass, metal, plastic,polymer (e.g., a rigid polymer such as polyethylene, polypropylene,polyamide, polycarbonate), etc. In some embodiments, the reservoir 150may be formed of a material that can be broken or punctured to releasethe contents of the reservoir 150 (e.g., plastic or glass). Thereservoir 150 may have an opening through which the medication can beintroduced into the reservoir 150 and/or selective selectively releasedtherefrom. In some embodiments, the reservoir 150 can include a vent.

The grip portion 140 can be formed of any suitable material, with atleast the distal end (e.g., the optional plate) being formed of arelatively rigid material capable of applying suitable pressure to theapplicator pad 110. For example, the grip portion 140 (or at least abody of a first portion of the grip 140) can be formed of a rigidpolymer such as polyethylene, polypropylene, polyamide, and/orpolycarbonate.

The reservoir 150 may be contained, in whole or in part, within theapplicator pad 110, or may be coupled thereto via a fluid coupling 155,such as a tube, wick, etc. The medication(s) may be selectively releasedfrom the reservoir 150 so that the medication(s) can be received in theapplicator pad 110, e.g. by the release mechanism 160. The releasemechanism 160 may be, for example a valve, which may be opened toestablish fluidic communication between the reservoir 150 and theapplicator pad 110, directly or via fluid coupling 155, and may also beselectively closed to fluidically isolate the medication(s) in thereservoir 150. The release mechanism may be a removable or frangible capor other closure closing an opening in reservoir 150. The reservoir 150may itself be frangible, e.g., formed of glass that may be readilybroken or at least partially of a material that bursts when the contentsof the reservoir 150 are above a threshold pressure, and themedication(s) can be released from the reservoir 150 by causing orallowing the reservoir 150 to be broken. As noted above, in someembodiments the reservoir 150 may be a part of the applicator pad 110.For example, the material of the applicator pad 100 may be soaked orsaturated with medication(s), and enclosed with the applicator seal 120(e.g., a film or other thin layer of material impermeable to andnon-reactive with the medication(s)). The medication(s) can be releasedfrom the reservoir 150 by removing the applicator seal 120, exposing thesurface of the applicator pad 110 so that the medication(s) can bedelivered to the wound tissue with which the surface of the applicatorpad 110 is placed in contact.

In some embodiments, volume and material of the applicator pad 110 canbe selected such that the amount of medication(s) contained in one ormore reservoirs 150, whether separate from the applicator pad 110 orincorporated into the applicator pad 110, or the amount of medication(s)can be pre-soaked into the applicator pad 110 such that the applicatorpad 110 is about 35% saturated (i.e., contains about 35% of the amountof the medication(s) that it is capable of containing). In someembodiments, the applicator pad 110 can be configured to be betweenabout 67 and about 100% saturated by the amount of medication(s). Insome embodiments, the applicator pad 110 is configured to be betweenabout 25 and about 50% saturated by the amount of medication(s). In someembodiments, the applicator pad 110 can be pre-soaked or filled to holda metered dose of medication. In some embodiments, the applicator pad110 can be configured such that the volume of medication(s) is effectiveto treat the wound but such that the medication does not travel acrossthe user’s skin outside of the treatment area (e.g., down a user’s armor leg) (e.g., configured to be about 35% saturated or between about 25%and about 50% saturated).

The applicator pad 110 can be any suitable shape and/or size that is,preferably, sufficient to cover the target wound. For example, theperimeter of the applicator pad 110 can be formed as a circle, an oval,an ellipse, a square, a rounded square, a rectangle, a roundedrectangle, a triangle, a pentagon, a hexagon, or any other suitableshape. As described above, target wound sizes to be covered by theapplicator pad 110 may be, for example, less than about 3 centimeters inlength and/or width. In some embodiments, for example, the applicatorpad 110 can have a square perimeter having side lengths of about 1.5inches. In some embodiments, the applicator pad 110 can have a smallerarea. In some embodiments, the applicator pad 110 can have a surfacearea between about 3.0 cm² and about 7.0 cm². In some embodiments, theapplicator pad 110 can have a surface area between about 7.0 cm² andabout 12.0 cm². In some embodiments, the applicator pad 110 can have asurface area of between about 2 cm² and about 25 cm². In someembodiments, the applicator pad 110 can have a surface area betweenabout 3 cm² and about 10 cm² or between about 10 cm² and about 20 cm².For example, the surface area may be about 2 cm², about 3 cm², about 4cm², about 5 cm², about 6 cm², about 7 cm², about 8 cm², about 9 cm²,about 10 cm², about 11 cm², about 12 cm², about 13 cm², about 14 cm²,about 15 cm², about 16 cm², about 17 cm², about 18 cm², about 19 cm²,about 20 cm², about 21 cm², about 22 cm², about 23 cm², about 24 cm², orabout 25 cm².

The applicator device 170 may be any suitable device manipulable by auser to dispose the applicator pad 110 into a desired location, e.g.,adjacent a wound WD, and to deposit the applicator pad 110 in thedesired location. For example, the applicator device 170 may be amechanical syringe that includes a barrel having a distal end suitablefor attachment to the applicator pad 110 and a proximal end that may begrasped by the user. In some embodiments, the reservoir 150, the releasemechanism 160, and/or the fluid coupling 155 can be disposed within thebarrel (e.g., between a plunger and the applicator pad 110). In someembodiments, the applicator device 170 can include a plunger movablerelative to the barrel and to which a user can apply distally directedforce to engage the distal end of the plunger with the reservoir 150 andto cause the contents of the reservoir 150 to be urged distally throughthe barrel, out of the distal end of the barrel, and into contact withthe applicator pad 110. For example, the reservoir 150 can include abreakable neck portion that separates from a body portion of thereservoir 150 to release liquid from the reservoir 150 in response tothe reservoir 150 being urged against an internal ramp or incline. Asanother example, a neck portion of the reservoir 150 can be broken fromthe reservoir due to engagement between a deformable sidewall of theapplicator device 170 and the neck portion due to manipulation of thesidewall by a user.

In some embodiments, the reservoir 150 can include a weakened orpre-scored area (e.g., a circumferential region or sidewall region)configured to preferentially break when a breaking force is applied tothe weakened or pre-scored area. For example, in some embodiments, theweakened or pre-scored area can be at a mid-point location of thereservoir 150 along a central axis of the reservoir 150, adjacent ashoulder of the reservoir 150, and/or can be on or near a first (e.g., adistal) or a second (e.g., a proximal) end of the reservoir 150. Thereservoir 150 can be configured to break (e.g., at a weakened orpre-scored area) due to a rotational, bending, and/or orthogonal force(relative to or along the central axis of the reservoir 150) applied tothe reservoir 150. In some embodiments, such a rotational, bending,and/or orthogonal force can be applied via twisting and/or bending thegrip 140 within which the reservoir 150 is disposed. In someembodiments, the breaking force can be applied via displacing (e.g.,squeezing) a portion of the grip (e.g., a deformable sidewall portion)into sufficiently forceful contact with a sidewall of the reservoir 150to break the reservoir 150 and release the contents of the reservoir150. In some embodiments, the breaking force can be applied via rotatingor translating a second portion of the grip 140 relative to a firstportion of the grip 140 to apply the breaking force to the reservoir150.

In some embodiments, the release mechanism 160 can include a forceconcentrating component (also referred to as a stress concentratingcomponent) (e.g., a ball such as a steel ball or projection such as aconvex or sharp tipped projection like a carbide tip) disposed on aninner surface of the grip 140 and configured to be urged toward asidewall of the reservoir 150 (e.g., as a result of bending of the grip140, squeezing or pushing an exterior portion of the grip 140 toward thereservoir 150, or rotating a second portion of the grip 140 relative toa first portion of the grip 140) to concentrate a breaking force againsta sidewall or end of the reservoir 150 and break (e.g., shatter) thereservoir 150. In some embodiments, the grip 140 can include a notchedfeature in a sidewall of the grip 140 such that the grip 140 can be moreeasily bent about a preferential axis or plane including the notchedfeature.

In some embodiments, the reservoir 150 and/or the grip 140 can bedisposed in a vertical orientation during a wetting of the applicatorpad 110 with the contents of the reservoir 150 and/or during applicationof pressure to the applicator pad 110 when disposed on a wound of thesubject such that the reservoir 150 is elongated along a longitudinalaxis intersecting a plane containing the applicator pad 110 in theinitial configuration of the system 100. In some embodiments, thecontents of the reservoir 150 can be configured to flow from thereservoir 150 to the applicator pad 110 through an open distal end ofthe grip 140. In some embodiments, the reservoir 150 and/or the grip 140can be disposed in a horizontal orientation during a wetting of theapplicator pad 110 with the contents of the reservoir 150 and/or duringapplication of pressure to the applicator pad 110 when disposed on awound of the subject such that the reservoir 150 is elongated along alongitudinal axis disposed substantially parallel to a plane containingthe applicator pad 110 in the initial configuration of the system 100.In some embodiments, the contents of the reservoir 150 can be configuredto flow from the reservoir 150 to the applicator pad 110 through asidewall of the grip 140.

In some embodiments, the applicator device 170 can include a filter (notshown) between the reservoir 150 and the applicator pad 110 to preventunwanted material (e.g., particles above a certain size and/or glasspieces) from reaching the applicator pad 110. In some embodiments, theapplicator device 170 may not contain the reservoir 150, the releasemechanism 160, and/or the fluid coupling 155, but instead just provide ahandle by which the user may hold the applicator pad 110 to be able toapply the applicator pad 110 to the target wound tissue and applydistributed pressure to the applicator pad 110 to maintain pressurebetween the applicator pad 110 against the target wound tissue.

The grip 140 may be used to provide a distributed force (e.g., auniformly distributed force) to the applicator pad 110, e.g., toincrease the pressure that the applicator pad 110 may apply to targetwound tissue during use, to enhance hemostasis. The grip 140 may beimplemented in a variety of ways, including those described in specificembodiments below. For example, the grip 140 may include a plate (alsoreferred to herein as a “fixation plate”) disposed on a distal end ofand extending laterally from a handle portion of the grip 140 andconfigured to contact and apply a distributed force against theapplicator pad 110. In some implementations, the plate can be shaped andsized such that the plate has a larger length and width than the targetwound tissue such that the plate can urge a sufficiently large portionof the applicator pad 110 into contact with the target wound tissue andmaintain uniformly distributed pressure between the applicator pad 110and the target wound tissue for a period of time. Thus, the grip 140 canbe used to provide a sufficient hemostatic force against the targetwound tissue (e.g. to generate sufficient pressure given the stiffnessor modulus of the material(s) of which the applicator pad 110 isformed). In some embodiments, the grip 140 or a portion of the grip maybe deformable (e.g., squeezable) to urge fluid from the reservoir 150disposed within the grip.

In some embodiments, the applicator device 170 can selectively releasethe applicator pad 110. For example, the grip 140 can releasably engagewith the applicator pad 110 via the pad connector 148 to apply theapplicator pad 110 to a surface of the patient (e.g., to the targetwound tissue). The pad connector 148 can disengage from the applicatorpad 110 such that the grip 140 and pad connector 148 can be separatedfrom the applicator pad 110, leaving the applicator pad 110 on thesurface of the patient. In some embodiments, the pad connector 148 caninclude one or more adhesive strips configured to couple the grip 140 tothe applicator pad 110 and to be removed from the grip 140 and/or theapplicator pad 110 when the applicator pad 110 is disposed in contactwith the wound of the subject without displacing the applicator pad 110relative to the wound such that the grip 140 can be separated from theapplicator pad 110 without displacing the applicator pad 110 relative tothe wound. In some embodiments, the pad connector 148 can includecomplementary hook-and-loop fastener portions coupled to the grip 140and the applicator pad 110 such that the grip 140 can be releasablycoupled to the applicator pad 110 via decoupling the complementaryhook-and-loop fastener portions. In some embodiments, the pad connector148 can include a first engagement feature coupled to the applicator pad110 and a second complementary engagement feature coupled to the grip140. The second complementary engagement feature can be configured toreleasably engage with the first engagement feature (e.g., via receivinga portion of the first engagement feature within an opening of thesecond engagement feature due to, for example, relative rotation betweenthe features, or via receiving a portion of the first engagement featurebetween opposing arms of the second engagement feature). In someembodiments, the pad connector 148 can include a latch portion disposedon the grip 140 configured to engage with a hook portion disposed on theapplicator pad 110.

In some embodiments, the applicator pad 110 can include or be coupled tothe pad retainer 135, which can be configured to maintain the applicatorpad 110 in contact with the target wound tissue. The pad retainer 135can include, for example, adhesive on a skin-contacting side of theapplicator pad 110 (e.g., disposed around at least a portion of aperimeter of the applicator pad 110). In some embodiments, the padretainer 135 can include an adhesive foam disposed about a perimeter ofthe applicator pad 110. In some embodiments, the pad retainer 135 caninclude adhesive strips having a first portion coupled to an uppersurface of the applicator pad 110 and having a second portion configuredto be coupled to a subject’s skin to retain the applicator pad 110 inplace relative to a wound on the skin. In some embodiments, the padretainer 135 can include a bandage configured to be placed over at leasta portion of the applicator pad 110. In some embodiments, the bandagecan be formed as a wrap configured to be wrapped around a portion of thesubject’s body including the wound (e.g., an arm or a leg). In someembodiments, the bandage can be formed as a bandage having an adhesiveperimeter greater than the perimeter of the applicator pad 110 andconfigured to be applied over the top of the applicator pad 110. In someembodiments, the bandage can include a convex portion configured to bealigned with the wound and placed in contact with the upper surface ofthe applicator pad 110 such that, when the applicator pad 110 isdisposed on the wound and the bandage is applied over the applicator pad110, the convex portion can apply targeted pressure to the wound via theapplicator pad 110 that is greater than if the bandage did not include aconvex portion. In some embodiments, after a period of time, the convexportion can be removed from the subject, leaving the applicator pad 110in place in contact with the wound.

In some embodiments, the applicator device 170 can be implemented as apipette. The pipette may be configured in a manner most suitable for theaccuracy and precision needed for the size and location of the wound.For example, the pipette may be configured to be positioned within apatient’s nostril.

The bleeding treatment system 100 may include a user guide 190. The userguide 190 may include instructions for operation of the bleedingtreatment system 100 to treat a person experiencing a wound requiringcessation of bleeding. The instructions may be in the form of textualand/or graphical information, which may be presented on fixed substrate(e.g. paper) or on a display (e.g. screen), and/or may use other sensorymodalities, including audible (spoken instructions) and/or tactile(haptic feedback to the user). The user guide 190 may be disposed on(e.g. printed on) or coupled to (e.g. mechanically attached) any one ormore component(s) of the bleeding treatment system 100, including theapplicator device 170, the packaging 190, the applicator pad 110, and/orthe reservoir 150. The user guide 190 may be separate from any of thecomponents of the bleeding treatment system 100, but may be associatedtherewith, e.g. disposed in the packaging 195 along with the othercomponents of the bleeding treatment system 100. In some embodiments,the user guide 190 may be implemented in whole or in part in softwareusable on a device such as smart phone, e.g. may be the form of an “app”that can be downloaded onto the smart phone and launched by a user inpreparation for using the bleeding treatment system 100.

In some embodiments, the user guide 190 or another informational labeldisposed on or included with the system 100 can include an informationlabel including user instructions such as: “Only apply only tosuperficial bleeding areas less than 1 inch. Press down with the topicalapplicator pad over the wound for 5 minutes. Place an adhesive bandageover the wound. If bleeding does not stop, seek professional medicaltreatment. If you feel weak or dizzy, call 911 immediately and do notuse this device. Not to be used in the mouth. Not to be used on deepwounds. Do not use if you have a history of seizures. Do not use forpenetrating wounds or puncture wounds (gunshot, knife, etc.).”

In some embodiments, the user guide 190 or another informational labeldisposed on or included with the system 100 can include an informationlabel including user instructions such as: “Only apply only tosuperficial bleeding wounds 3 inches or less in length. Push the releasemechanism to break the medication. Allow the medication to fully coverthe topical applicator. Press down with the device over the wound for 10minutes. Place an adhesive bandage over the wound. If bleeding does notstop or if you feel dizzy, weak, or fatigued, seek professional medicaltreatment IMMEDIATELY. Not to be used in the mouth. Not to be used ondeep wounds. Do not use if you have a history of seizures. Do not usefor penetrating wounds or puncture wounds (gunshot, knife, etc.). Do notdrink this medication. Keep away from children or infants.”

In some embodiments, the user guide 190 or another information labeldisposed on or included with the system 100 can include one or morestatements indicating one or more of the following: (i) remove theapplicator cap before pressing down with the device over the wound; and(ii) peel the topical applicator from the rest of the device and use anadhesive bandage to keep the topical applicator on the wound.

In some embodiments, the user guide 190 or another informational labelor stamp on the system 100 can include an expiration date. For example,the system 100 may have a shelf life from a date of manufacture of threeyears, more than three years, or less than three years. In someembodiments, the user guide 190 or another informational label or stampon the system 100 can include a lot number and/or a date of manufacture.In some embodiments, the user guide 190 or another informational labelor stamp on the system 100 can include a bar code and/or Quick Response(QR) code.

The packaging 195 may be implemented in the same manner as any knownmedical device packaging, to contain the other components of thebleeding treatment system 100, to protect the components from theenvironment, and optionally to preserve sterility of the components. Thepackaging 195 is preferably configured to be readily opened by a user,e.g. by peeling a cover from a tray, when the user desires to access anduse bleeding treatment system 100. The packaging 195 may be implementedin many other ways, including for example a bag or box. The system 100is preferably intended for a single user and one wound site application.The system 100 is preferably intended to be discarded after use, and mayoptionally include a container for safe disposal. In some embodiments,the system 100 can be originally supplied to the user in the packaging195 that can also be used for disposal. In some embodiments, thepackaging 195 and/or disposal container can be a re-sealable bag and/orcan include a biohazard label and/or disposal instructions.

The medication(s) described herein may be any medication that would bedesirable to deliver to the patient experiencing a wound requiringcessation of bleeding, preparatory to or as part of treatment of thewound. Categories of medications may include vasoconstrictors,antifibrinolytics, antibiotics, recombinant clotting factor medications,local anesthetics, analgesics, buffering agents, calcium,alcohols/antiseptics (e.g., a chlorhexidine solution such as a solutionof chlorhexidine and isopropyl alcohol and/or ethyl alcohol), or anycombination thereof. A vasoconstrictor may be useful to help bleedingvessels constrict prior to or simultaneously with administration of ahemostatic medication such as an antifibrinolytic, and may desirably bedelivered to the target wound tissue at or around the site of thebleeding before, during, and/or after application of applicator pad 110to the target wound tissue. Suitable vasoconstrictors may includephenylephrine, oxymetazoline (Afrin), and epinephrine. Anantifibrinolytic agent may be useful to prevent blood clot breakdown,and may also desirably be delivered to the wound tissue at or around thesite of the bleeding before, during, and/or after application ofapplicator pad 110 to the target wound tissue. Suitableantifibrinolytics may include aminocaproic acid, tranexamic acid (TXA)(e.g., dry or lyophilized TXA or a liquid formulation including TXA),aprotinin, protaaminomethylbenzoic acid, and fibrinogen. Protamine, areversal agent for the anticoagulant heparin could be used before,during, or after use of the above medications. The medication(s) caninclude, for example, protamine sulfate. As noted above, the bleedingtreatment system 100 and medication(s) may be particularly helpful fortreatment of patients who are susceptible to bleeding or for whom it maybe difficult to achieve hemostasis, such as patients who are takinganticoagulation and/or antiplatelet medications (identified above).

In some embodiments, the medication can include a pharmaceuticalcomposition including a therapeutically effective amount of TXA, one ormore antibiotic(s), one or more anesthetic(s), one or more non-steroidanti-inflammatory drug(s), and/or an excipient or carrier thatfacilitates local administration. For example, in some embodiments, thetherapeutically effective amount of tranexamic acid is between 1-70% byweight of the composition. In some embodiments, the one or moreantibiotic(s) can include sulfacetamide, mupirocin, erythromycin,clindamycin, sulfadiazine, mafenide, tetracycline, bacitracin, neomycin,and polymyxin B. In some embodiments, the one or more antibiotic(s) caninclude bacitracin, neomycin, and polymyxin B. In some embodiments, theexcipient or carrier permits the composition to remain in contact with ableeding wound. In some embodiments, the excipient or carrier comprisesan ointment, a cream, a liniment, a paste, a lotion, a gel, a hydrogel,a liposome, a spray, an aerosol, a solution, or an emulsion. In someembodiments, the excipient or carrier permits instillation of thecomposition. In some embodiments, the one or more anesthetic(s) caninclude lidocaine, proparacaine, procaine, tetracaine and combinationsthereof. In some embodiments, the one or more non-steroidanti-inflammatory drug(s) can include ketorolac, ketoprofen,flurbiprofen, bromfenac, diclofenac and/or combinations thereof.

In some embodiments, the medication can include analgesics, includingbut not limited to, opiates such as codeine, morphine, oxycodone, etc.;acetaminophen; anti-inflammatory agents, including nonsteroidalanti-inflammatory drugs, aspirin, etc.; antibiotics or anotherantimicrobial drugs or compounds; antihistamines (e.g., cimetidine,chloropheniramine maleate, diphenhydramine hydrochloride, andpromethazine hydrochloride); antifungal agents; ascorbic acid; rutin;thrombin; botanical agents; etc.; and combinations thereof. Themedication can also include magnesium sulfate, sodium metaphosphate,calcium chloride, dextrin, and combinations thereof.

In some embodiments, the medication can include sterile water and/ornormal saline (which can be included as a carrier). In some embodiments,the medication can include between about 50% and about 100% tranexamicacid and between about 50% and about 0% sterile water or normal saline.In some embodiments, the medication can include between about 10% andabout 50% tranexamic acid and between about 90% and about 50% sterilewater or normal saline. In some embodiments, the medication can includebetween about 50% and about 90% tranexamic acid and between about 10%and about 50% sterile water or normal saline. In some embodiments, themedication can include at least one of a liquid and a gel. In someembodiments, the medication can have a viscosity between about 0.75millipascal-seconds and about 0.98 millipascal-seconds at about +25° C.

In some embodiments, the reservoir 150 can include an activation liquidsuch as sterile water or saline and the applicator pad 110 can include adried (e.g., lyophilized) medication configured to be activated by theactivation liquid upon release of the activation liquid from thereservoir 150. In some embodiments, the applicator pad 110 can includedried medication configured to be activated by blood flowing from thewound when the applicator pad 110 is disposed in contact with the woundsuch that activation liquid disposed within the applicator device 170 isnot needed or is supplemental. In some embodiments, the applicator pad110 can include wetting agents to promote dissolution of the driedmedication.

In some embodiments, the medication(s) may comprise an antifibrinolyticin an amount of about 50 mg/mL to about 300 mg/mL, including about 50mg/mL, about 100 mg/mL, about 150 mg/mL, about 200 mg/mL, about 250mg/mL, or about 300 mg/mL. In some embodiments, the medication(s) mayalso include a colored dye to indicate that the medication(s) has beendispensed to the wound and is of a composition to be human viewablebased on skin color and blood color (before and after clotting). Inother embodiments, the medication(s) may not contain a colored dye.

In some embodiments, the amount of medication(s) (e.g., of anantifibrinolytic such as TXA) included in the reservoir and/or providedfrom the reservoir to the target wound (e.g., the therapeuticallyeffective amount) can be between about 1 mg and about 20 mg, betweenabout 1 mg and about 5 mg, between about 5 mg and about 10 mg, betweenabout 10 mg and about 15 mg, between about 15 mg and about 20 mg, and/orbetween about 10 mg and about 20 mg. In some embodiments, a largeramount of medication(s) can be included for treatment of larger targetwound sizes.

In some embodiments, the reservoir(s) 150 and/or release mechanism 160are configured such that a metered dose can be provided from thereservoir (e.g., to the applicator pad 110 and/or to the patient). Themetered dose (e.g., of IV TXA) can be the amount of liquid disposedwithin the reservoir(s) 150 prior to use of the system 100. In someembodiments, the metered dose can be between about 1.5 mL and about 2.5mL, between about 2.5 mL and about 4.5 mL, between about 3 mL and about10 mL, between about 3 mL and about 7 mL, between about 1 mL and about20 mL, between about 1 mL and about 1.5 mL, between about 2.5 mL andabout 5 mL, between about 5 mL and about 10 mL, between about 10 mL andabout 15 mL, or between about 15 mL and about 20 mL. For example, thereservoir 150 can include a metered dose of about 1 mL, or about 2 mL,or about 3 mL, or about 4 mL, or about 5 mL, or about 6 mL, or about 7mL, or about 8 mL, or about 9 mL, or about 10 mL, or about 11 mL, orabout 12 mL, or about 13 mL, or about 14 mL, or about 15 mL, or about 16mL, or about 17 mL, or about 18 mL, or about 19 mL, or about 20 mL.

A method of using bleeding treatment system 100 to treat a woundrequiring cessation of bleeding is shown in FIG. 4 and illustrated withreference to FIGS. 3A to 3D. In some embodiments, the bleeding treatmentsystem 100 can be operated with one hand (e.g., the hand of the subjecthaving the wound in need of treatment or the hand of a caregiver). Asshown in FIG. 4 and illustrated in FIG. 3A, in some embodiments, theapplicator device 170 can be removed, at 202, from the packaging 195.The user guide 190 can optionally be reviewed or initiated, at 204. At206, optionally, medication(s) can be released from the reservoir(s) 150and transferred to the applicator pad 110. The applicator pad 110 can beexposed, at 208, for delivery to a wound WD in skin SK (e.g., viaremoval of the optional applicator seal 120).

As shown in the flow chart of a method 200 shown in FIG. 4 , and asillustrated in FIG. 3B, the applicator pad 110 can be delivered, at 210,to the wound WD in skin SK. As shown in FIG. 3A and referenced above, insome embodiments, the applicator pad 110 can be delivered to the woundWD in skin SK within, extending from, or coupled to the applicatordevice 170 such that the applicator pad 110 is in contact with the woundWD and an area of skin SK surrounding the wound WD.

The applicator pad 110 can be pressed, at 212, against the wound WD inthe skin SK. For example, the applicator pad 110 can be pressed againstthe wound WD in the skin SK via applying pressure (e.g., pressuredistributed across the wound WD) to the applicator pad 110 using thegrip 140. Alternatively or additionally, in some embodiments, theapplicator pad 110 can be pressed against the wound WD in the skin SKvia the applicator pad 110 via applying pressure to the applicator pad110 with fingers of the user.

Medication(s) can be allowed to be released, at 214, from the applicatorpad 110 to the wound WD. For example, in some embodiments, medication(s)can be released from the reservoir 150 via interaction with the releasemechanism 160 such that the medication(s) flow to the applicator pad 110via the fluid coupling 155 and then from the applicator pad 110 to thewound WD. In some embodiments, as described above, the applicator pad110 may include medication(s) prior to use of the system 100 (e.g., viabeing pre-soaked), such that removal of the applicator seal 120 andapplication of the applicator pad 110 to the wound WD (and/or pressureapplied to the applicator pad 110 when in contact with the wound WD)allows or causes medication(s) to travel into contact with the wound WD.In some embodiments, rather than or in addition to releasingmedication(s) from the reservoir 150, an activation liquid such assaline can be released from the reservoir 150 to activate medication(s)included in the applicator pad 110 (e.g., in an initial dry state) suchthat the combination of medication(s) from the applicator pad and theactivation liquid can flow into contact with the wound WD. In someembodiments, blood from the wound WD can contact and activatemedication(s) in the applicator pad 110 (e.g., in an initial dry state)such that the combination of medication(s) from the applicator pad andthe blood can flow into contact with the wound WD.

The applicator pad 110 can be maintained, at 216, against the wound WDwith pressure applied by the grip 140 against the wound WD. At 218,hemostasis can be evaluated. For example, a hemostasis condition of thewound WD can be evaluated to determine if the hemostasis condition meetsa target hemostasis condition. The hemostasis condition of the wound WDcan be evaluated via any suitable method. For example, after a presetperiod of time (e.g., five or ten to thirty minutes), the applicator pad110 can be removed and the wound WD checked to determine whether or nothemostasis has been achieved.

In some embodiments, after evaluating hemostasis at 218, the applicatorpad 110 can continue to be maintained, at 220, against the wound WDwhile continuing to apply pressure to the wound WD and hemostasis can bereevaluated until achieved. For example, if the hemostasis condition ofthe wound WD fails to meet a target hemostasis condition, the applicatorpad 110 can be maintained against the wound WD applying pressure to thewound WD for a period of time. The hemostasis condition can then bereevaluated to determine if the target hemostasis condition has beenmet. Such a cycle can continue until the target hemostasis condition hasbeen met, at which time the applicator pad 110 can be removed from thewound WD.

In some embodiments, as illustrated in FIG. 3C, prior to removal of theapplicator pad 110 from the wound WD, pressure can be released, at 222,against the wound WD. For example, in the instance of a grip 140 beingused to apply pressure to the applicator pad 110, the grip 140 can bedisengaged from the applicator pad 110 to reduce the pressure of theapplicator pad 110 against the wound WD. In some embodiments, theapplicator pad 110 can be maintained against the wound WD, at 224, afterthe pressure is released (e.g., after removal of the grip 140). In someembodiments, the applicator pad 110 can be maintained in place againstthe wound WD by the pad retainer 135. In some embodiments, a bandage orwrap can be applied to the applicator pad 110 to maintain the applicatorpad 110 against the wound WD for a period of time. In some embodiments,the applicator pad 110 can continue to apply pressure to the wound WDafter removal of the grip 140 (e.g., due to remaining in contact withthe wound WD). In some embodiments, the applicator pad 110 can continueto apply pressure to the wound WD at least in part due to swelling ofthe applicator pad 110 or the blood absorption pad 130 due to liquid(e.g., blood) absorption. As illustrated in FIG. 3D, the applicator pad110 can be removed, at 226, from the wound WD.

FIG. 5 is a schematic illustration of a bleeding treatment system 300.The system 300 can be the same or similar in structure and/or functionto any of the bleeding treatment systems described herein. The system300 includes an applicator device 370, an applicator pad 310, and anoptional reservoir 350. The applicator device 370 includes a grip 340having a first portion 342 (also referred to as a “first section”). Thefirst portion 342 optionally defines an interior space 343. In someembodiments, the first portion 342 optionally defines an open distal endsuch that the interior space 373 can be fluidically coupled to theapplicator pad through the distal end of the first portion 342.

The first portion 342 can be formed in any suitable shape. For example,the first portion 342 can include a cylindrical or tubular housing. Insome embodiments, the first portion 342 can include or be coupled to aplate 341 disposed at the distal end of the first portion 342 andconfigured to apply pressure to the applicator pad 310 and thus a targetwound. The plate 341 may form a bottom surface of the grip 340. In someembodiments, such as when the grip 340 does not include a reservoir, theplate 341 can be formed as a continuous plate. In some embodiments, theplate 341 may be formed as a flange (e.g., a circumferential flange)extending from a bottom edge of the first portion 342.

In some embodiments, the grip 340 includes an applicator seal 320configured to cover at least the distal or skin-contacting surface ofthe applicator pad 310 to prevent contamination of the applicator pad310 and, optionally, leakage from or drying of the applicator pad 310prior to use. The applicator seal 320 can be formed, for example, as afilm (e.g., a peelable film). In some embodiments, the applicator seal320 can be formed of a shrink wrap material covering the distal end ofthe applicator pad 310 and positioned over at least a portion of thelength of the first portion 342.

The applicator pad 310 can be the same or similar in structure and/orfunction to any of the applicator pads described herein. For example,the applicator pad 310 can include and/or be coupled to an optionalblood absorption pad 330 and/or an optional pad retainer 335. The bloodabsorption pad 330 and the pad retainer 335 can be the same or similarin structure and/or function to any of the blood absorption pads or padretainers, respectively, described herein.

As shown in FIG. 5 , the reservoir 350 can be disposed in the optionalinterior space 343. In some embodiments, the reservoir 350 can beconfigured to be displaced and/or pressurized such that liquid (e.g.,medication and/or activating liquid such as saline) within the reservoir350 flows from the reservoir 350 to the applicator pad 310. For example,the reservoir 350 can optionally include a release mechanism 360 and/ora fluid coupling 355 that may be the same or similar in structure and/orfunction to any of the release mechanisms and/or fluid couplingsdescribed herein. In some embodiments, the fluid coupling 355 can be aportion of the interior space 343 defined by the housing of the firstportion 342 via which liquid can flow from the reservoir 350 to theapplicator pad 310. In some embodiments, the fluid coupling 355 includesa separate tubular member defining a lumen through which liquid can flowfrom the reservoir 350 to the applicator pad 310.

In some embodiments, the delivery device 370 can include an optionalsecond portion 344 (also referred to as a “second section”). In someembodiments, the second portion 344 can be configured to engage with thereservoir 350 and/or the release mechanism 360 to initiate transfer ofliquid from the reservoir 350 to the applicator pad 310. In someembodiments, the second portion 344 can be formed as a plunger andadvanced by a user (e.g., a self-administering home user, a caregiver,or a patient) relative to the first portion 342 (e.g., at leastpartially into the interior space 343 or while in contact with thereservoir 350 to advance the reservoir 350 itself) to apply pressure tothe reservoir 350. In some embodiments, the second portion 344 can bedisposed on a sidewall of the first portion 342 and configured to beurged laterally into the interior space 343 to apply pressure to thereservoir 350.

In some embodiments, the interior space 343 can be at least partiallydefined by an inner surface of a sidewall of the grip 340, and can bedefined by the first portion 342 and/or the second portion 344. In someembodiments, the inner surface and/or the outer surface of the sidewallof the grip 340 (including the first portion 342 and the second portion344) can have any suitable shape, such as a circular cylindrical shape,an oval cylindrical shape, an elliptical cylindrical shape, a tubularshape having two opposing flat sides coupled together by two opposingcurved sides, and/or a prism shape, including a cube, rounded squareprism, rectangular prism, rounded rectangular prism, triangular prism,pentagonal prism, hexagonal prism, etc. In some embodiments, the innersurface of the grip 340 defining the interior space 343 includes one ormore rounded or beveled edges. In some embodiments, the inner surface ofthe grip 340 defining the interior space 343 includes a roundedrectangular prism shape with one or more rounded edges. In someembodiments, the interior space 343 is cylindrical.

In some embodiments, the release mechanism 360 can be coupled to thereservoir 350 and configured to transition from a closed condition to anopen condition to allow medication to flow from the reservoir 350 and tothe applicator pad 310 via the fluid coupling 355 in response to apressure above a threshold pressure within the reservoir 350 (e.g.,applied by the distal end of the second portion 344). For example, insome embodiments, the release mechanism 360 can include a weakened orfrangible portion of a sidewall of the reservoir 350. In someembodiments, the release mechanism 360 includes a valve that transitionsfrom a closed to an open condition upon an internal pressure of thereservoir 350 rising above a threshold pressure. In some embodiments,the release mechanism 360 can be a frangible portion of the reservoir350 configured to break when pushed against an internal obstruction (notshown) such as a ramp portion within the interior space 343 such thatthe medication within the reservoir 350 can be released from thereservoir 350. In some embodiments, the first portion 342 can include afilter (not shown) between the reservoir 350 and the applicator pad 310to prevent unwanted material from reaching the applicator pad 310.

Prior to use, the applicator device 370 can be disposed in an initialconfiguration. In the initial configuration, the applicator pad 310 canbe coupled to the distal end of the grip 340. The applicator seal 320can cover the applicator pad 310. To use the applicator device 370, theapplicator seal 320 can be optionally removed and the grip 340 can beused to apply the applicator pad 310 to a wound. In embodimentsincluding the reservoir 350, the release mechanism 360, and the fluidcoupling 355, liquid (e.g., medication and/or activating agent such assaline) can be contained within the reservoir 350 prior to andoptionally after applying the applicator pad 310 to the wound. Torelease the liquid from the reservoir 350 such that the liquid flows tothe applicator pad 310, the second portion 344 can be configured to bemoved relative to the first portion 342 (e.g., via translation relativeto the first portion 342, radial movement relative to the first portion342, and/or rotational movement relative to the first portion 342) toengage with the reservoir 350 and/or the release mechanism 360.

The applicator pad 310 can optionally be pressed against target woundtissue using the grip 340. The applicator pad 310 can optionally bemaintained relative to the wound (e.g., without maintaining the grip 340against the applicator pad 310) via coupling the applicator pad 310 tothe skin via the pad retainer 335. The applicator pad 310 can beoptionally separated from the applicator pad 310 via releasing theapplicator pad 310 from the pad connector 348.

FIGS. 6A and 6B are a perspective view and a cross-sectional view of ableeding treatment system 400. FIG. 6C is a cross-sectional view of thebleeding treatment system with a reservoir 450 of the bleeding treatmentsystem 400 not shown. The system 400 can be the same or similar instructure and/or function to any of the delivery or treatment systemsdescribed herein. For example, the system 400 includes an applicatordevice 470, a reservoir 450, and an applicator pad 410. The applicatordevice 470 includes a grip 440 defining an interior space 443 and havingan open distal end, a closed proximal end, and extending along a centrallongitudinal axis A. The grip 440 has a first portion 442 and a secondportion 444, the second portion 444 being movable relative to the firstportion 442. The reservoir 450 can be formed as an ampoule having a neckportion 452 and a body portion 454. The neck portion 452 can be narrowerthan the body portion 454 (e.g., can have a smaller diameter). Thereservoir 450 can be disposed within the interior space 443 of the grip440. The reservoir 450 can be oriented such that the neck portion 452 isdistal of the body portion 454 and therefore closer to the open end ofthe grip 440. The interior space 443 can be at least partially definedby an inner surface of a sidewall of the grip 440, and can be defined bythe first portion 442 and/or the second portion 444. The grip 440 (e.g.,the inner surface and/or the outer surface) can be formed as shown inFIG. 6A, having a tubular shape having two opposing flat sides coupledtogether by two opposing curved sides. In some embodiments, the grip 440can have any suitable shape, such as is described above with respect tothe grip 340.

The first portion 442 can include a plate 431 having a distal or bottomsurface extending laterally relative to the central axis A of the grip440. The applicator pad 410 can be disposed on a distal end of the firstportion 442 (e.g., coupled to the distal surface of the plate 431). Thefirst portion 442 can include a ramp portion 462 (also referred to as afirst release mechanism portion) extending partially into the interiorspace 443 of the first portion 442 such that the neck portion 452 cancontact the ramp portion 462. The first portion 442 can also include oneor more retaining portions 447 (e.g., flexible tab or bump portions)extending toward the central axis A of the first portion 442 andconfigured to contact a shoulder of the body portion 454 of thereservoir 450 as shown in FIG. 6B to retain the reservoir 450 in aninitial proximal position until sufficient force is applied to aproximal end of the reservoir 450 to advance the reservoir 450 relativeto the one or more retaining portions 447. The first portion 442 canalso include one or more grip features 445 on an exterior surface of asidewall of the first portion 442 to improve the grip of the user duringhandling of the grip 440. The grip features 445 can include any suitablesurface feature to increase grip or friction, such as one or more ridges(as shown in FIG. 6A), concave and/or convex curvatures, and/or atextured or course surface.

The second portion 444 can include a projection 464 (also referred to asa second release mechanism portion). The first portion 442 and thesecond portion 444 can be coupled such that at least a portion of thesecond portion 444 can be advanced relative to the first portion 442towards a distal end of the first portion 442. For example, the firstportion 442 can be coupled to the second portion 444 via any suitablecoupling mechanism, such as, for example, a flexible circumferentialportion. To release liquid within the reservoir 450 such that the liquidflows to the applicator pad 410, the second portion 444 can be advanceddistally relative to the first portion 442 (e.g., via pressing on aproximal end of the second portion 444) such that the second releasemechanism portion 464 applies a force to the proximal end of thereservoir 450 to urge the reservoir 450 distally such that contactbetween the neck portion 452 of the reservoir 450 and the ramp 462causes the neck portion 452 to separate (e.g., break) from a remainderof the reservoir 450 and allow liquid to flow from the reservoir 450,out of the distal end of the first portion 442, and to the applicatorpad 410, resulting in the applicator pad 410 being wetted with theliquid from the reservoir 450.

In some embodiments, the first portion 442 can include a filter toprevent unwanted material (e.g., particles above a certain size and/orglass pieces) from reaching the applicator pad 410. Before or afterwetting the applicator pad 410 with the liquid, the distal surface ofthe applicator pad 410 can be disposed against a wound of the subject.The grip 440 can then be maintained against the applicator pad 410 suchthat the plate 431 applies distributed pressure to the applicator pad410 for a period time, as described with respect to the method 200above. In some embodiments, the first portion 442 and/or the secondportion 444 can be deformable (e.g., squeezable) to urge fluid (e.g.,medication) from the reservoir 450. In some embodiments, the bleedingtreatment system 400 can be operated with one hand (e.g., the hand ofthe subject having the wound in need of treatment). For example, theuser can place a thumb on the proximal end of the second portion 444 andwrap the remaining fingers of the same hand around the sidewall of thegrip 440 (e.g., around the first portion 442), with at least some of theremaining fingers in contact with the grip features 445. While grippingthe grip 440 in this configuration, either before or after pressing theapplicator pad 410 against the wound, the user can press the secondportion 444 toward the applicator pad 410 with the user’s thumb torelease liquid from the reservoir 450 as described above.

FIGS. 7A-7D are schematic illustrations of a perspective, front, side,and cross-sectional view, respectively, of a bleeding treatment system500 in an initial configuration. FIGS. 7E-7H are schematic illustrationsof a perspective, front, side, and cross-sectional view, respectively,of the bleeding treatment system 500 in wetting configuration. Thesystem 500 can be the same or similar in structure and/or function toany of the delivery or treatment systems described herein, such as, forexample, the bleeding treatment system 400. For example, the system 500includes an applicator device 570, a reservoir 550, and an applicatorpad 510. The applicator device 570 includes a grip 540 defining aninterior space 543 and having an open distal end, a closed proximal end,and extending along a central longitudinal axis D. The grip 540 has afirst portion 542 and a second portion 544, the second portion 544 beingmovable relative to the first portion 542. The reservoir 550 can beformed as an ampoule having a neck portion 552 and a body portion 554.The neck portion 552 can be narrower than the body portion 554 (e.g.,can have a smaller diameter). The reservoir 550 can be disposed withinthe interior space 543 of the grip 540. The reservoir 550 can beoriented such that the neck portion 552 is distal of the body portion554 and therefore closer to the open end of the grip 540. The interiorspace 543 can be partially defined by an inner surface of a sidewall ofthe first portion 542 and the second portion 544.

The first portion 542 can include a plate 531 having a distal or bottomsurface extending laterally relative to the central axis D of the grip540. The applicator pad 510 can be disposed on a distal end of the firstportion 542 (e.g., coupled to the distal surface of the plate 531). Thefirst portion 542 can include a ramp portion 562 (also referred to as afirst release mechanism portion) extending partially into the interiorspace 543 of the first portion 542 such that the neck portion 552 cancontact the ramp portion 562. The first portion 542 can also include oneor more retaining portions 547 (e.g., flexible tab or bump portions)extending toward the central axis A of the first portion 542 andconfigured to contact a shoulder of the body portion 554 of thereservoir 550 as shown in FIG. 6B to retain the reservoir 550 in aninitial proximal position until sufficient force is applied to aproximal end of the reservoir 550 to advance the reservoir 550 relativeto the one or more retaining portions 547. The first portion 542 canalso include one or more grip features 545 on an exterior surface of asidewall of the first portion 542 to improve the grip of the user duringhandling of the grip 540.

The second portion 544 can include a projection 564 (also referred to asa second release mechanism portion) extending into the interior space543. The first portion 542 and the second portion 544 can be coupledsuch that at least a portion of the second portion 544 can be advancedrelative to the first portion 542 towards a distal end of the firstportion 542. For example, the second portion 544 can include a slidableengagement portion 544A and the first portion 542 can include areceiving portion 544B having a corresponding shape and a largerperimeter than the outer diameter of the slidable engagement portion544A such that the slidable engagement portion 544A can be translatedinto the receiving portion 544B (e.g., via pressing on a proximal end ofthe second portion 544 and/or gripping opposing sidewalls of the secondportion 544 and advancing the second portion 544 distally). During thetranslation of the slidable engagement portion 544A into the receivingportion 544B, the second release mechanism portion 564 can apply a forceto the proximal end of the reservoir 550 to urge the reservoir 550distally such that contact between the neck portion 552 of the reservoir550 and the ramp 562 causes the neck portion 552 to separate (e.g.,break) from a remainder of the reservoir 550 and allow liquid to flowfrom the reservoir 550, out of the distal end of the first portion 542,and to the applicator pad 510, resulting in the applicator pad 510 beingwetted with the liquid from the reservoir 550.

In some embodiments, the first portion 542 can include a filter (e.g.,disposed between the ramp 562 and the distal opening of the grip 540) toprevent unwanted material (e.g., particles above a certain size and/orglass pieces) from reaching the applicator pad 510. Before or afterwetting the applicator pad 510 with the liquid, the distal surface ofthe applicator pad 510 can be disposed against a wound of the subject.The grip 540 can then be maintained against the applicator pad 510 suchthat the plate 531 applies distributed pressure to the applicator pad510 for a period time, as described with respect to the method 200above. In some embodiments, the bleeding treatment system 500 can beoperated with one hand (e.g., the hand of the subject having the woundin need of treatment). For example, the user can place a thumb on theproximal end of the second portion 544 and wrap the remaining fingers ofthe same hand around the sidewall of the grip 540 (e.g., around thefirst portion 542), with at least some of the remaining fingers incontact with the grip features 545. While gripping the grip 540 in thisconfiguration, either before or after pressing the applicator pad 510against the wound, the user can press the second portion 544 toward theapplicator pad 510 with the user’s thumb to release liquid from thereservoir 550 as described above.

FIG. 8 is a schematic illustration of a bleeding treatment system 600.The bleeding treatment system 600 can be the same or similar instructure and/or function to any of the bleeding treatment systemsdescribed herein, such as the bleeding treatment system 400 or thebleeding treatment system 500. For example, the bleeding treatmentsystem 600 includes an applicator device 670, a reservoir 650, and anapplicator pad 610. The applicator device 670 includes a cover 620configured to be releasably coupled to the applicator pad 610 and,optionally, to the distal end of the first portion 642. The applicatordevice 670 includes a grip 640 including a first portion 642 and asecond portion 644. The first portion 642 has an open distal end and anopen proximal end such that the reservoir 650 can be inserted into theproximal end of the first portion 642 and disposed in the interior space643. The second portion 644 can then be coupled to the proximal end ofthe first portion 642. The second portion 644 includes a projection 664configured to extend into the internal space 643, contact the reservoir650, and urge the reservoir and/or liquid within the reservoir towardthe applicator pad 610 disposed on the distal end of the first portion642.

To use the bleeding treatment system 600 to treat a wound and ceasebleeding of the wound, the reservoir 650 can be inserted into theinterior space 643 of the first portion 642. The second portion 644 canbe coupled to a proximal end of the first portion 642. The cover 620 canbe removed from the applicator pad 610. The second portion 644 can thenbe advanced distally in the direction of arrow A to apply pressure tothe reservoir 650. Using any suitable reservoir and release mechanismstructure, such as any of the reservoir and release mechanism structuresdescribed herein, liquid can be released from the reservoir 650 and flowto the applicator pad 610 such that medication M is disposed on theapplicator pad 610.

FIGS. 9A and 9B are a perspective view and a cross-sectional view of ableeding treatment system 700. FIG. 9C is a cross-sectional view of thebleeding treatment system with a reservoir 750 of the bleeding treatmentsystem 700 not shown. The system 700 can be the same or similar instructure and/or function to any of the delivery or treatment systemsdescribed herein. For example, the system 700 can include an applicatordevice 770, a reservoir 750, and an applicator pad 710. The applicatordevice 770 can include a grip 740 defining an interior space 743 andhaving an open distal end, a closed proximal end, and extending along acentral longitudinal axis B. The grip has a first portion 742 and asecond portion 744, the second portion 744 being movable laterallyrelative to the first portion 742. The reservoir 750 can be formed as anampoule having a neck portion 752 and a body portion 754. The neckportion 752 can be narrower than the body portion 754 (e.g., can have asmaller diameter). The reservoir 750 can be disposed within the interiorspace 743 of the grip 740. The reservoir 750 can be oriented such thatthe neck portion 752 is distal of the body portion 754 and thereforecloser to the open end of the grip 740. The interior space 743 can be atleast partially defined by an inner surface of a sidewall of the grip740, and can be defined by a combination of the first portion 742 andthe second portion 744. The grip 740 (e.g., the inner surface and/or theouter surface) can be formed as shown in FIG. 8A, having a tubular shapehaving two opposing flat sides coupled together by two opposing curvedsides. In some embodiments, the grip 740 can have any suitable shape,such as is described above with respect to the grip 340.

The first portion 742 can include a plate 731 having a distal or bottomsurface extending laterally relative to the central axis B of the grip740. The applicator pad 710 can be disposed on a distal end of the firstportion 742 (e.g., coupled to the distal surface of the plate 431). Thefirst portion 742 can also include one or more retaining portions (notshown) (e.g., flexible tab or bump portions) extending toward thecentral axis B of the first portion 742 and configured to contact ashoulder of the body portion 754 of the reservoir 750 to retain thereservoir 750 in a proximal position. In some embodiments, rather thanor in addition to including one or more retaining portion that contactthe shoulder of the body portion 754, the first portion 742 can includeretaining portions such as adhesive and/or an inner sidewall infrictional contact with the body portion 754 to retain the body portion754 in a position in which the neck portion 752 is radially aligned withthe second portion 744.

The second portion 744 can be formed as a deformable sidewall portiondisposed in an opening defined by the first portion 742. The secondportion 744 can optionally include a projecting portion 762 (alsoreferred to as a release mechanism portion) extending and/or deformablelaterally toward the central axis B and toward the neck portion 752 ofthe reservoir 750 in an initial configuration. The second portion 744can be deformed via being pressed in by a finger of a user such that theprojecting portion 762 is urged into sufficient contact with the neckportion 752 to break the neck portion 752 and release the liquid withinthe reservoir 750. In some embodiments, the second portion 744 can besufficiently deformable that the second portion 744 can be urged intosufficient contact with the neck portion 752 to break the neck portion752 such that the second portion 744 operates as the release mechanismportion without including the projecting portion 762. In someembodiments, the second portion 744 can be formed, for example, ofsilicone or a similar elastomeric material. Although not shown, in someembodiments, the grip 740 can include a ramp portion that can be thesame or similar in structure and/or function to ramp portion 562. Theramp portion can be disposed relative to the neck portion 552 and thesecond portion 744 such that the second portion 744 can be deformed tourge the neck portion 552 into the ramp portion such that the neckportion 552 breaks relative to the body portion 554.

As shown in FIG. 9B, the first portion 742 can include a closed proximalend and an open distal end. The first portion 742 can optionally includea projecting portion 764 coupled to a flexible end of the first portion742 and configured to contact a proximal end of the reservoir 750 andurge the reservoir 750 distally (or urge liquid to flow from thereservoir 750) when pressed by a user’s finger.

To release liquid within the reservoir 750 such that the liquid flows tothe applicator pad 710, the second portion 744 can be deformed laterallyrelative to the neck portion 752 (e.g., via pressing on the secondportion 744 with a finger of the user such as a thumb) such that thecontact between the second portion 744 and the neck portion 752 of thereservoir 750 causes the neck portion 752 to separate (e.g., break) fromthe body 754 of the reservoir 750 and allows liquid to flow from thereservoir 750, out of the distal end of the first portion 742, and tothe applicator pad 710, resulting in the applicator pad 410 being wettedwith the liquid from the reservoir 750.

The second portion 744 can include one or more grip features 745 on anexterior surface of the second portion 744 to improve the grip of theuser during handling of the grip 740. The grip features 745 can includeany suitable surface feature to increase grip or friction, such as oneor more ridges (as shown in FIG. 8A), concave and/or convex curvatures,and/or a textured or course surface.

In some embodiments, the first portion 742 can include a filter toprevent unwanted material (e.g., particles above a certain size and/orglass pieces) from reaching the applicator pad 710. Before or afterwetting the applicator pad 710 with the liquid, the distal surface ofthe applicator pad 710 can be disposed against a wound of the subject.The grip 740 can then be maintained against the applicator pad 710 suchthat the plate 731 applies distributed pressure to the applicator pad710 for a period time, as described with respect to the method 200above. In some embodiments, the first portion 742 and/or the secondportion 744 can be deformable (e.g., squeezable) to urge the medicationfrom the reservoir 750 (e.g., after the neck portion 752 has beenseparated from the body portion 750). In some embodiments, the bleedingtreatment system 700 can be operated with one hand (e.g., the hand ofthe subject having the wound in need of treatment). For example, theuser can place a thumb on the second portion 744 and wrap the remainingfingers of the same hand around the sidewall of the grip 740 (e.g.,around the first portion 742). While gripping the grip 740 in thisconfiguration, either before or after pressing the applicator pad 710against the wound, the user can press the second portion 744 toward theneck portion 752 with the user’s thumb to release liquid from thereservoir 750 as described above.

FIGS. 10A and 10B are a perspective view and a cross-sectional view of ableeding treatment system 800. FIG. 10C is a cross-sectional view of thebleeding treatment system with a reservoir 850 of the bleeding treatmentsystem 800 not shown. The system 800 can be the same or similar instructure and/or function to any of the delivery or treatment systemsdescribed herein. For example, the system 800 can include an applicatordevice 870, a reservoir 850, and an applicator pad 810. The applicatordevice 870 can include a grip 840 defining an interior space 843 andhaving an open distal end, a closed proximal end, and extending along acentral longitudinal axis C. The grip has a first portion 842 and asecond portion 844, the second portion 844 being movable relative to thefirst portion 842. The reservoir 850 can be formed as an ampoule havinga neck portion 852 and a body portion 854. The neck portion 852 can benarrower than the body portion 854 (e.g., can have a smaller diameter).The reservoir 850 can be disposed within the interior space 843 of thegrip 840. The reservoir 850 can be oriented such that the neck portion852 is distal of the body portion 854 and therefore closer to the openend of the grip 840. The interior space 843 can be at least partiallydefined by an inner surface of a sidewall of the grip 840, and can bedefined by the first portion 842 and/or the second portion 844. The grip840 (e.g., the inner surface and/or the outer surface) can be formed asshown in FIG. 9A, having a cylindrical shape. In some embodiments, thegrip 840 can have any suitable shape, such as is described above withrespect to the grip 340.

The first portion 842 can include a plate 831 having a distal or bottomsurface extending laterally relative to the central axis C of the grip840. The applicator pad 810 can be disposed on a distal end of the firstportion 842 (e.g., coupled to the distal surface of the plate 831). Thefirst portion 842 can include a ramp portion 862 (also referred to as afirst release mechanism portion) extending partially into the interiorspace 843 of the first portion 842 such that the neck portion 852 cancontact the ramp portion 862. The first portion 842 can also include oneor more retaining portions (not shown) (e.g., flexible tab or bumpportions) extending toward the central axis C of the first portion 842and configured to contact a shoulder of the body portion 854 of thereservoir 850 as shown in FIG. 9B to retain the reservoir 850 in aninitial proximal position until sufficient force is applied to aproximal end of the reservoir 850 to advance the reservoir 850 relativeto the one or more retaining portions. The first portion 842 can alsoinclude one or more grip features (not shown) on an exterior surface ofa sidewall of the first portion 842 to improve the grip of the userduring handling of the grip 840. The grip features can include anysuitable surface feature to increase grip or friction, such as one ormore ridges, concave and/or convex curvatures, and/or a textured orcourse surface.

The second portion 844 can include a distally-facing inner surface 864(also referred to as a second release mechanism portion). The firstportion 842 and the second portion 844 can be coupled such that thesecond portion 844 can be advanced relative to the first portion 842towards a distal end of the first portion 842. For example, the firstportion 842 can be coupled to the second portion 844 via any suitablecoupling mechanism, such as, for example, threads or a slidable frictionfit. The second portion 844 can have a larger inner diameter than anouter diameter of the proximal end of the first portion 842 such thatthe second portion 844 can be disposed in contact with an outer surfaceof the first portion 842. The reservoir 850 can be disposed in aninitial position within the interior space 843 such that the proximalend of the reservoir is near or adjacent to the distally-facing innersurface 864 and can be advanced distally due to the second portion 844being displaced distally. To release liquid within the reservoir 850such that the liquid flows to the applicator pad 810, the second portion844 can be advanced distally relative to the first portion 842 (e.g.,via pressing on a proximal end of the second portion 844) such that theinner surface 864 applies a force to the proximal end of the reservoir850 to urge the reservoir 850 distally such that contact between theneck portion 852 of the reservoir 850 and the ramp 862 causes the neckportion 852 to separate (e.g., break) from a remainder of the reservoir850 (e.g., the body 854) and allows liquid to flow from the reservoir850, out of the distal end of the first portion 842, and to theapplicator pad 810, resulting in the applicator pad 810 being wettedwith the liquid from the reservoir 850.

In some embodiments, the first portion 842 can include a filter toprevent unwanted material (e.g., particles above a certain size and/orglass pieces) from reaching the applicator pad 810. Before or afterwetting the applicator pad 810 with the liquid, the distal surface ofthe applicator pad 810 can be disposed against a wound of the subject.The grip 840 can then be maintained against the applicator pad 810 suchthat the plate 831 applies distributed pressure to the applicator pad810 for a period time, as described with respect to the method 200above. In some embodiments, the first portion 842 and/or the secondportion 844 can be deformable (e.g., squeezable) to urge the medicationfrom the reservoir 850. In some embodiments, the bleeding treatmentsystem 800 can be operated with one hand (e.g., the hand of the subjecthaving the wound in need of treatment). For example, the user can placea thumb on the proximal end of the second portion 844 and wrap theremaining fingers of the same hand around the sidewall of the grip 840(e.g., around the first portion 842). While gripping the grip 840 inthis configuration, either before or after pressing the applicator pad810 against the wound, the user can press the second portion 844 towardthe applicator pad 810 with the user’s thumb to release liquid from thereservoir 850 as described above.

FIGS. 11A and 11B are cross-sectional views of a bleeding treatmentsystem 900 with and without a reservoir 950 shown, respectively. Thesystem 900 can be the same or similar in structure and/or function toany of the delivery or treatment systems described herein. For example,the system 900 can include an applicator device 970, a reservoir 950,and an applicator pad 910. The applicator device 970 can include a grip940 defining an interior space 943 and having an open distal end, aclosed proximal end, and extending along a central longitudinal axis D.The grip has a first portion 942 and a second portion 944, the secondportion 944 being movable relative to the first portion 942. Thereservoir 950 can be formed as an ampoule having a neck portion 952 anda body portion 954. The neck portion 952 can be narrower than the bodyportion 954 (e.g., can have a smaller diameter). The reservoir 950 canbe disposed within the interior space 943 of the grip 940. The reservoir950 can be oriented such that the neck portion 952 is distal of the bodyportion 954 and therefore closer to the open end of the grip 940. Theinterior space 943 can be at least partially defined by an inner surfaceof a sidewall of the grip 940, and can be defined by the first portion942 and/or the second portion 944. The grip 940 (e.g., the inner surfaceand/or the outer surface) can be formed having a cylindrical shape. Insome embodiments, the grip 940 can have any suitable shape, such as isdescribed above with respect to the grip 340.

The first portion 942 can include a plate 931 having a distal or bottomsurface extending laterally relative to the central axis D of the grip940. The applicator pad 910 can be disposed on a distal end of the firstportion 942 (e.g., coupled to the distal surface of the plate 931). Thefirst portion 942 can include a ramp portion 962 (also referred to as afirst release mechanism portion) extending partially into the interiorspace 943 of the first portion 942 such that the neck portion 952 cancontact the ramp portion 962. The first portion 942 can also include oneor more retaining portions (not shown) (e.g., flexible tab or bumpportions) extending toward the central axis D of the first portion 942and configured to contact a shoulder of the body portion 954 of thereservoir 950 to retain the reservoir 950 in an initial proximalposition until sufficient force is applied to a proximal end of thereservoir 950 to advance the reservoir 950 relative to the one or moreretaining portions. The first portion 942 can also include one or moregrip features (not shown) on an exterior surface of a sidewall of thefirst portion 942 to improve the grip of the user during handling of thegrip 940. The grip features can include any suitable surface feature toincrease grip or friction, such as one or more ridges, concave and/orconvex curvatures, and/or a textured or course surface.

The grip can include a spring portion 946. The first portion 942 and thesecond portion 944 can be coupled such that the second portion 944 canbe advanced relative to the first portion 942 towards a distal end ofthe first portion 942. For example, the first portion 942 can be coupledto the second portion 944 via any suitable coupling mechanism, such as,for example, threads or a slidable friction fit. The second portion 944can have a larger inner diameter than an outer diameter of the proximalend of the first portion 942 such that the second portion 944 can bedisposed in contact with an outer surface of the first portion 942. Thereservoir 950 can be disposed in an initial position within the interiorspace 943 such that the proximal end of the reservoir is near oradjacent the distally-facing inner surface 964 and can be advanceddistally due to the second portion 944 being displaced distally. In someembodiments, the spring portion 946 can be configured to transition froman initial configuration to an expanded or compressed configuration tobring the reservoir 950 into contact with the ramp 962. For example, thespring portion 946 can be activatable to urge the ramp 962 away from theapplicator pad 910 and into breaking contact with the neck portion 952.In some embodiments, the spring portion 946 may be activatable to pullor push the reservoir 950 into contact with the ramp 962. The secondportion 944 can be engaged with the spring portion 946 such thatdepression or twisting of the second portion 944 causes the springportion 946 to activate. Thus, to release liquid within the reservoir950 such that the liquid flows to the applicator pad 910, the secondportion 944 can be twisted or advanced distally relative to the firstportion 942 (e.g., via rotating or pressing on a proximal end of thesecond portion 944) such that the spring portion 946 is released from aninitial configuration. The spring portion 946 can then translate thereservoir 950 and/or the ramp 962 such that contact between the neckportion 952 of the reservoir 950 and the ramp 962 causes the neckportion 952 to separate (e.g., break) from a remainder of the reservoir950 (e.g., the body 954) and allows liquid to flow from the reservoir950, out of the distal end of the first portion 942, and to theapplicator pad 910, resulting in the applicator pad 910 being wettedwith the liquid from the reservoir 950.

In some embodiments, the first portion 942 can include a filter toprevent unwanted material (e.g., particles above a certain size and/orglass pieces) from reaching the applicator pad 910. Before or afterwetting the applicator pad 910 with the liquid, the distal surface ofthe applicator pad 910 can be disposed against a wound of the subject.The grip 940 can then be maintained against the applicator pad 910 suchthat the plate 931 applies distributed pressure to the applicator pad910 for a period time, as described with respect to the method 200above. In some embodiments, the first portion 942 and/or the secondportion 944 can be deformable (e.g., squeezable) to urge the medicationfrom the reservoir 950. In some embodiments, the bleeding treatmentsystem 900 can be operated with one hand (e.g., the hand of the subjecthaving the wound in need of treatment). For example, the user can placea thumb on the proximal end of the second portion 944 and wrap theremaining fingers of the same hand around the sidewall of the grip 940(e.g., around the first portion 942). While gripping the grip 940 inthis configuration, either before or after pressing the applicator pad910 against the wound, the user can press the second portion 944 towardthe applicator pad 910 with the user’s thumb to release liquid from thereservoir 950 as described above.

FIG. 12 is a schematic illustration of an applicator pad 1010 incombination with a blood absorption pad 1030, which can be the same orsimilar in structure and/or function to any of the applicator pads andblood absorption pads, respectively, described herein. As shown, theapplicator pad 1010 can be surrounded by the blood absorption pad 1030such that the applicator pad 1010 and the absorption pad 1030 areconcentric. Thus, in some embodiments, the applicator pad 1010 can beshaped, sized, and disposed (e.g., relative to a grip) such that onlythe applicator pad 1010 and not the blood absorption pad 1030 includesor is contacted by liquid (e.g., medication) from a reservoir. In someembodiments, a liquid impermeable divider 1032 can be disposed betweenthe applicator pad 1010 and the blood absorption pad 1030. In someembodiments, rather than surrounding the applicator pad 1010, the bloodabsorption pad 1030 can only partially surround or be disposed adjacentto the applicator pad 1010. Although the applicator pad 1010 is shown ashaving a rectangular shape with curved edges, as described above withrespect to applicator pad 110, in some embodiments the applicator pad1010 can have any suitable shape, such as circular, ovular, or square.

In some embodiments, rather than including a reservoir within a grip ofan applicator device, an applicator pad, such as any of the applicatorpads described herein, can be prefilled with medication. For example,FIG. 13 is a schematic illustration of a bleeding treatment system 1100.The bleeding treatment system 1100 can be the same or similar instructure and/or function to any of the other bleeding treatment systemsdescribed herein. For example, the bleeding treatment system 1100 caninclude an applicator device 1170 having a grip 1140, an applicator pad1110 (also referred to as a topical applicator pad), and an applicatorseal 1120. In some embodiments, the applicator pad 1110 can be a porousapplicator (e.g., a sponge type material) configured to retain liquidmedication M and only apply the liquid medication M to a wound site onphysical contact. The applicator pad 1110 can be prefilled (e.g.,presoaked) with liquid or dry medication M. The grip 1140 can include aplate 1141 having a diameter equal to or larger than the applicator pad1110 such that the grip 1140 can be used to apply distributed pressureto the applicator pad 1110 when the applicator pad 1110 is in contactwith a wound. The plate 1141 can be rigid or semi-rigid or have asurface opposite the surface contacting the applicator pad 1110 that isrigid or semi-rigid to apply uniform pressure to the applicator pad1110. In some embodiments, the plate 1141 can be flexible. The plate1141 can function as an insulating mechanism configured to isolate ahand applying pressure from the wound site and the medication in theapplicator pad 1110. To use the system 1100, the applicator seal 1120can be removed from the applicator pad 1110 and the grip 1110 can beused to apply the applicator pad 1110 to a wound such that themedication flows to the wound and to maintain pressure against the woundby applying pressure to the applicator pad 1110.

FIG. 14 is a flow chart of a method 1200 of using a bleeding treatmentsystem, such as any of the bleeding treatment systems described herein.The method 1200 can be for reducing bleeding at a wound site of asubject taking a medication that predisposes the subject to increasedand/or prolonged bleeding. In some embodiments, the steps of method 1200can be implemented by the subject, a caregiver, a healthcare provider, aveterinary care provider, etc. In step 1202, the wound can be cleanedand elevated (e.g., by the subject having the wound and/or by acaregiver or clinician) to reduce bleeding. In some embodiments, thewound is cleaned (e.g., with soap and water). In some embodiments, thewound is elevated above the level of the heart of the patient.

In step 1204, whether the subject (e.g., a patient) is on a medication(e.g., an anticoagulant drug or antiplatelet drug) that predisposes thesubject to increased and/or prolonged bleeding can be determined. Forexample, a caregiver or clinician can check to see if such a medicationhas been taken by the subject within a relevant time period (e.g., bychecking a medical record or asking the subject). In some embodiments,step 1204 can be not included and a user can proceed directly to step1206 described below. In some embodiments, step 1204 can be performedafter step 1206 if the wound is still bleeding, and the steps of themethod 1200 can proceed from there.

In step 1206, if the subject is determined not to have taken amedication that predisposes the subject to increased and/or prolongedbleeding within a relevant time period, the firm pressure can be appliedto the wound using a sterile gauze pad (e.g., by the subject or acaregiver). In some embodiments, the firm pressure can be applied for afirst period of time (e.g., a predetermined period of time). In someembodiments, for example, the first period of time can be about fiveminutes, between about four minutes and about six minutes, less thanabout four minutes, greater than about five minutes, greater than aboutsix minutes. After the first period of time, the pressure can beremoved. If the wound is no longer bleeding, the subject or a caregivercan apply a bandage to the wound. If the wound is still bleeding, thenstep 1208 can be performed as described below and/or medical attentionmay be sought.

In step 1208, if the subject is determined to have taken a medicationthat predisposes the subject to increased and/or prolonged bleedingwithin a relevant time period, or if applying firm pressure for thefirst period of time as described in step 1206 has not caused bleedingto stop, firm pressure can be applied to the wound using a topicalapplicator pad containing a metered dose of medication (e.g., TXA suchas intravenous (IV) TXA) for a second period of time (e.g., a secondpredetermined period of time) (e.g., five minutes) such that themedication contacts the wound. In some embodiments, the second period oftime can be greater than the first period of time. In some embodiments,the second period of time can be less than the first period of time. Insome embodiments, the metered dose can be between three and ten mLand/or include between about 300 and about 1000 mg of medication.

In step 1210, the pressure can be removed by the subject or a caregiver(e.g., via removing the applicator pad) and the wound can be checked tosee if the wound is still bleeding. In step 1212, if the wound is nolonger bleeding, a bandage can be applied to the wound by the subject ora caregiver. In step 1214, if the wound is still bleeding, the subjector a caregiver can reapply firm pressure to the wound using the topicalapplicator pad for an additional predetermined time period (e.g., for anadditional five minutes). In some embodiments, a new topical applicatorpad (containing a metered dose or not containing a metered dose ofmedication) may be used. In step 1216, the pressure can be removed andchecked to see if the wound is still bleeding. In step 1218, if thewound is no longer bleeding, a bandage can be applied to the wound ifneeded. In step 1220, if the wound is still bleeding, the subject canseek medical attention (with the help of a caregiver if needed).

FIGS. 15A-15E are schematic illustrations of a bleeding treatment system1300 in various stages of use. The system 1300 can be the same orsimilar in structure and/or function to any of the systems describedherein. For example, the system 1300 can include an applicator device1370, a reservoir (not shown), and an applicator pad 1310. As shown inFIG. 15A, the applicator pad 1310 can be coupled to the applicatordevice 1370 via a pad connector 1348. The pad connector 1348 can includeany suitable coupling mechanism, such as any of the coupling mechanismsand pad connector described herein. For example, the applicator device1370 can include a sliding mechanism or a latch disengageable with anengagement feature associated with the applicator pad 1310 such that theengagement feature associated with the applicator pad 1310 can bereleased from the applicator device 1370 before or after being appliedto a wound WD, as shown in FIG. 15B.

In some embodiments, the applicator pad 1310 can be coupled to theapplicator device 1370 via adhesive strips 1303 that are releasable fromthe applicator device 1370 via, for example, the pad connector 1348which can operate as a release mechanism to allow the adhesive strips1303 to contact skin of a patient to secure the pad connector 1348 to awound WD. Thus, in the first configuration shown in FIG. 15C, theapplicator pad 1310 can be coupled to the applicator device 1370. Asshown in FIG. 15D, the applicator pad 1310 and the adhesive strips 1303can be decoupled from the applicator device 1370. The applicator pad1310 can then be secured to the subject at the location of the wound viathe adhesive strips 1303.

FIGS. 16A-16C are schematic illustrations of a perspective, front, andcross-sectional view, respectively, of a bleeding treatment system 1400in wetting configuration in which a reservoir 1450 has been broken torelease the contents of the reservoir 1450. FIGS. 16D-16F are schematicillustrations of a perspective, front, and cross-sectional view,respectively, of the bleeding treatment system 1400 in a separatedconfiguration in which a grip 1440 of the system 1400 has been decoupledfrom an applicator pad 1410. The system 1400 can be the same or similarin structure and/or function to any of the delivery or treatment systemsdescribed herein, such as, for example, the bleeding treatment system500. For example, the system 1400 includes an applicator device 1470,the reservoir 1450, and the applicator pad 1410. The applicator device1470 includes a grip 1440 defining an interior space 1443 and having anopen distal end, a closed proximal end, and extending along a centrallongitudinal axis. The applicator device 1470 includes a filter 1471(e.g., disposed between a ramp 1462 of the grip 1440 and the distalopening of the grip 1440) to prevent unwanted material (e.g., particlesabove a certain size and/or glass pieces) from reaching the applicatorpad 1410.

As shown in FIGS. 16A-16F, the system 1400 can include a bandage 1412coupled to a portion of an upper surface of the applicator pad 1410 andextending beyond an outer perimeter of the applicator pad 1410. Althoughshown as surrounding a periphery of the applicator pad 1410, in someembodiments the bandage can extend beyond opposing portions or sides ofthe applicator pad 1410 but not in all directions. The bandage 1412 candefine one or more openings 1412A adjacent the upper surface of theapplicator pad 1450 such that fluid can flow through the openings andinto wetting contact with the applicator pad 1450. In some embodiments,the one or more openings 1412A can collectively have a surface area andperimeter equal to or smaller than the surface area and perimeter of thedistal opening of the grip 1440. In some embodiments, the bandage 1412can include a liquid permeable layer or portion covering the one or moreopenings 1412A. In some embodiments, the bandage 1412 can be adhesivelycoupled to the upper surface of the applicator pad 1450 via one or moreadhesive portions.

The system 1400 can be placed on a surface of a subject with theapplicator pad 1410 and the bandage 1412 in contact with the surface,the applicator pad 1410 contacting a wound of the subject and thebandage 1412 surrounding the applicator pad 1410. The applicator device1470 can be transitioned from an initial configuration to the wettingconfiguration shown in FIGS. 16A-16C via the same steps as describedwith respect to the system 500. After the contents of the reservoir 1450are released from the reservoir 1450 as shown in FIG. 16C, the contentscan flow through the filter 1471, through the one or more openings 1412Ain the bandage 1412, to the applicator pad 1410, and into contact withthe wound. The grip 1440 can be used to apply pressure to the applicatorpad 1410 and thus the wound (e.g., before and/or after wetting theapplicator pad 1410) by applying a downward pressure to the grip 1440with the distal end of the grip 1440 and/or the plate 1431 contactingthe applicator pad 1410.

In some embodiments, the applicator pad 1410 and the bandage 1412 can beleft on the skin of the subject such that the applicator pad 1410remains in contact with the wound, and the grip 1440 can be decoupledfrom the applicator pad 1410 and the bandage 1412 such that theapplicator pad 1410 is not displaced relative to the wound during thedecoupling. As shown in FIGS. 16D-16F, after decoupling the grip 1440from the applicator pad 1410 and/or the bandage 1412, the grip 1440 canbe discarded, leaving the applicator pad 1410 and the bandage 1412 inplace on the wound and skin of the subject.

The grip 1440 can be coupled to and/or decoupled from the applicator pad1410 and/or the bandage 1412 via any suitable decoupling methoddescribed herein. For example, as shown in FIGS. 17A and 17B, which aretwo different perspective views of the system 1400 including twoadhesive strips 1414 (also referred to as pad connectors), theapplicator device 1470 can be coupled to the bandage 1412 via removableadhesive strips 1414. The adhesive strips 1414 can be disposed incontact with an upper surface of the plate 1431 on either side of thegrip 1440 and can each have ends in contact with the bandage 1412 suchthat the adhesive strips 1414 secure the grip 1440 to the bandage 1412via the plate 1431. In some embodiments, the adhesive strips 1414 can beflexible but have low or no elasticity. To separate the grip 1440 fromthe bandage 1412 and the applicator pad 1410, each of the adhesivestrips 1414 can be peeled away from the bandage 1412 to release thebandage 1412 from the plate 1431.

In some embodiments, as shown in FIG. 18 , rather than includingadhesive strips that are peelable and have low or no elasticity, thesystem 1400 can include adhesive strips 1416 that have high elasticityand can be decoupled from the bandage 1412 and/or the plate 1431 viastretching a free end of each of the adhesive strips 1416 away from butwithin or near a plane containing the portion of the adhesive strip 1416(also referred to as pad connectors) adhesively coupled to the bandage1412 and/or the plate 1431 such that the adhesive strip 1416 is deformedand the adhesive contact between the adhesive strip 1416 and the bandage1412 and/or the plate 1431 is broken. For example, the adhesive strips1416 can include a synthetic rubber resin adhesive.

In some embodiments, an applicator pad can include or be coupled to arigid or semi-rigid backing portion that is configured to be releasablyengaged by a portion of an applicator device. For example, FIG. 19A is aschematic illustration of a system 1500 that can be the same or similarin structure and/or function to any of the other systems describedherein. The system 1500 can include an applicator device 1570 includinga grip 1540, an applicator pad 1510, and a reservoir (not identified)that is included within the applicator pad 1510 and/or within the grip1540. As shown in FIG. 19B, the applicator pad 1510 can be coupled(e.g., via adhesive) to a backing portion 1518 that can be rigid or morerigid than the applicator pad 1510. The backing portion 1518 can defineone or more openings (not shown in FIGS. 19A and 19B) such that fluidcan flow from the reservoir within the grip 1540 to the applicator pad1510 to wet the applicator pad 1510. The backing portion 1518 caninclude one or more pad retainer portions 1535 configured to be receivedby or otherwise coupled to complementary pad retainer portions (notshown) of the grip 1540 such that the grip 1540 can be adhered, clipped,latched, frictionally fit, hook-and-loop fastened, buttoned, orotherwise releasably coupled via any suitable coupling mechanism to thebacking portion 1518. After applying pressure to the backing portion1518 to push the applicator pad 1510 against the wound, the grip 1540can be decoupled from the backing portion 1518 by uncoupling thecomplementary pad retainer portions. As shown in FIG. 19A, the grip 1540can include a convex distal surface 1536 configured to apply targetedand increased pressure to the wound when a user presses the grip 1540into the applicator pad 1510 coupled to the wound. The convex distalsurface 1536 can include one or more openings to allow fluid flowthrough the convex distal surface 1536.

As shown in FIG. 19C, in some embodiments, the backing portion 1518 canbe curved and rigid such that the convex distal surface 1536 of the grip1540 can be seated in a concave upper surface of the backing portion1518 during wetting of the applicator pad 1510 and/or during applicationof pressure to the applicator pad 1510 and, thus, the wound. As shown inFIG. 19C, the backing portion 1518 can define one or more openings 1519such that fluid can flow from the reservoir within the grip 1540 to theapplicator pad 1510 to wet the applicator pad 1510.

As shown in FIG. 20 , which is a schematic illustration of a system1600, in some embodiments a backing portion 1618 can be releasablycoupled to an applicator pad 1610 via an attachment such as ahook-and-loop fastener 1635 (e.g., Velcro®) or releasable adhesive (notshown). The backing portion 1618 can include a convex distal surface1636 configured to apply pressure to the portion of the applicator pad1610 in contact with a wound when the applicator pad 1610 contacts awound and the backing portion 1618 is coupled to the applicator pad1610. After hemostasis occurs, the backing portion 1618 can be removedfrom the applicator pad 1610, leaving the applicator pad 1610 in placerelative to the wound.

FIG. 21 is a schematic illustration of a system 1700. The system 1700can be the same or similar in structure and/or function to any of thesystems described herein. For example, the system 1700 includes a grip1740 and an applicator pad 1710. The applicator pad 1710 can be coupledto a backing portion 1718 that may be configured as a bandage. Thebacking portion 1718 can include an adhesive covered by a peel-awayadhesive liner disposed on a distal surface of the backing portion. Theadhesive liner can be peeled away prior to placing the backing portion1718 on a subject’s skin so that the backing portion 1718 can be adheredto the skin via the adhesive. In some embodiments, the backing portion1718 can extend laterally from the grip 1740 prior to disposal on theskin as shown in FIG. 21 . In some embodiments, the backing portion 1718can be flush with the grip 1740 (e.g., extending upward along thesidewall of the grip 1740) and then folded down to adhere to the skin.In some embodiments, the backing portion 1718 can fully surround and/orextend circumferentially away from the applicator pad 1710. In someembodiments, the backing portion 1718 can extend along one axis of theapplicator pad 1710.

The backing portion 1718 and/or the applicator pad 1710 can include orbe coupled to a pad retainer portion 1735B extending away from theapplicator pad 1710 and configured to be releasably grasped by a padretainer portion 1735A of the grip 1740. The pad retainer portion 1735Aof the grip 1740 can include, for example, flexible arms configured toengage with a recess of the pad retainer portion 1735B such that thegrip 1740 and the applicator pad 1710 are coupled (e.g., during wettingand/or applying pressure to the wound). To separate the grip 1740 fromthe applicator pad 1710, the flexible arms can be pulled away from therecess of the pad retainer portion 1735B (e.g., via pulling on tabsextending from an outer surface of the grip 1740 or by squeezingengagement mechanisms (e.g., semicircular buttons) near or adjacent tothe distal end of the grip 1740 to activate a release mechanism suchthat the pad retainer portion 1735B is released) and the grip 1740 canbe removed from the pad retainer portion 1735B.

FIGS. 22A and 22B are cross-sectional and top views of a schematicillustration of a system 1800. The system 1800 can be the same orsimilar in structure and/or function to any of the systems describedherein. For example, the system 1800 includes a semi-rigid backingportion 1818 that may be configured as a bandage and an applicator pad1810. As shown, the semi-rigid backing portion 1818 can include a foamring 1818A surrounding the applicator pad 1810 and a backing layer 1818Bdisposed against the upper surface of the applicator pad 1810 andcoupled to the foam ring 1818A. The foam ring 1818A can adhesivelycouple the backing portion 1818 and the applicator pad 1810 to thesurface of the skin of the subject and apply compressive pressure to theapplicator pad 1810 to urge the applicator pad 1810 against a wound. Insome embodiments, the pressure applied to the applicator pad 1810 canactivated release of medication(s) from the applicator pad 1810.

In some embodiments, the contents of a reservoir can be configured toflow from the reservoir to an applicator pad through a sidewall of agrip containing the reservoir. For example, FIGS. 23A-23C are schematicillustrations of a system 1900 in various stages of operation. Thesystem 1900 can be the same or similar in structure and/or function toany of the systems described herein. For example, the system 1900includes an applicator device 1970, a reservoir 1950, and an applicatorpad 1910. The applicator device 1970 can include a grip 1940 defining aninterior space within which the reservoir 1950 can be disposed. Asshown, the grip 1940 can be disposed horizontally such that theapplicator pad 1910 is coupled to a sidewall of the grip 1940 and thegrip 1940 and/or the reservoir 1950 are elongated along a longitudinalaxis disposed substantially parallel to the applicator pad 1910 in theinitial configuration shown in FIG. 23A.

The grip 1940 can include a first portion 1942 and a second portion 1944collectively defining the interior space within which the reservoir 1950is disposed. The first portion 1942 can be configured to be bentrelative to the second portion 1944 as shown in FIG. 23B to cause thereservoir 1950 to break and the contents of the reservoir 1950 to flowfrom the reservoir 1950 to the applicator pad 1910. For example, thegrip 1940 can be bendable such that a first end of the grip 1940 can berotated relative to a second end of the grip 1940, causing an innersurface of the grip 1940 to apply pressure to the reservoir 1950 tosnap, crush, or otherwise break the reservoir 1950. In some embodiments,the grip 1940 can include a bendable hinge or notched feature near amidpoint of the grip 1940 such that the first portion 1942 can berotated relative to the second portion 1944 about the hinge or notch tocause the reservoir 1950 to break. In some embodiments, the grip 1940can include a force concentrating component 1909 such as a tippedprojection or a steel ball that can project from an inner surface of thegrip 1940 such that bending the grip 1940 pushes the force concentratingcomponent 1909 into breaking contact with a portion of the reservoir1950, causing the reservoir 1950 to break. In some embodiments, theforce concentrating component 1909 can be aligned with a weakened orpre-scored portion of the reservoir such that the reservoir will bepreferentially broken by the force concentrating component 1909 at theweakened or pre-scored portion. In some embodiments, a subject orcaregiver can use two hands to bend the first portion 1942 relative tothe second portion 1944 to break the reservoir 1950. In someembodiments, a subject or caregiver can place the system 1900 on a hardsurface (e.g., a table) and apply a downward orthogonal force againstthe grip 1940 such that the reservoir 1950 is urged into breakingcontact with the force concentrating component 1909 and the contents ofthe reservoir 1950 are released. In some embodiments, a subject orcaregiver can place the system 1900 directly against the wound with theapplicator pad 1910 against the wound, and can apply a force orthogonalto the wound to the grip 1940 such that the reservoir 1950 is urged intobreaking contact with the force concentrating component 1909 and thecontents of the reservoir 1950 are released. Thus, in some embodiments,a user can apply pressure to the grip 1940 using a palm of the user’shand, and that pressure can be concentrated to a particular location onthe reservoir 1950 by the force concentrating component 1909 to breakthe reservoir 1950.

After the reservoir 1950 is broken, the contents of the reservoir 1950can flow from the reservoir 1950 to the applicator pad 1910 through asidewall of the grip 1940. For example, the grip 1940 can define one ormore openings through which fluid can flow to the applicator pad 1910,which may be coupled or releasably coupled to a sidewall of the grip1940 and aligned with the openings. In some embodiments, the grip 1940can include a filter (not shown) disposed between the reservoir 1950 andthe applicator pad 1910 to prevent unwanted material (e.g., particlesabove a certain size and/or glass pieces) from reaching the applicatorpad 1910. For example, the filter can be disposed within or adjacent tothe one or more openings defined by the grip 1940.

In some embodiments, the grip 1940 can be releasably coupled to theapplicator pad 1910 using any of the releasable coupling mechanismdescribed herein such that, as shown in FIG. 23C, the grip 1940 can bedecoupled from the applicator pad 1910 after wetting the applicator pad1910. For example, before or after breaking the reservoir 1950 to wetthe applicator pad 1910, the applicator pad 1910 can be disposed incontact with a target wound. After applying pressure to the grip 1940 tobreak the reservoir 1950 and wet the applicator pad 1910, the grip 1940can be pressed against the applicator pad 1910 to apply pressure to thewound. After a period of time, the grip 1940 can be decoupled from theapplicator pad 1910, leaving the applicator pad 1910 disposed in contactwith the wound. In some embodiments, the applicator pad 1910 can includean adhesive portion on a skin-contacting surface of the applicator pad1910 (e.g., adjacent to a perimeter of the skin-contacting surface) toretain the applicator pad 1910 in place relative to the wound. In someembodiments, adhesive tabs can be applied to the applicator pad 1910 andthe skin of the subject to retain the applicator pad 1910 in placerelative to the wound. In some embodiments, as shown in FIG. 23C, abacking portion 1918, which may be the same or similar as any of thebacking portions or bandages described herein, can be placed over thetop of the applicator pad 1910 to apply compressive pressure to theapplicator pad 1910 and, thus, the wound, and/or to maintain theapplicator pad 1910 in place relative to the wound.

In some embodiments, a force concentrating component can be disposed ona first portion or a second portion of a grip and the second portion ofthe grip can be moved (e.g., rotated and/or translated) relative to afirst portion of the grip containing a reservoir to break the reservoirdue to contact between the reservoir and the force concentratingcomponent. For example, FIG. 24 is a schematic illustration of a system2000. The system 2000 can be the same or similar in structure and/orfunction to any of the systems described herein. For example, the system2000 includes a reservoir 2050, an applicator device 2070, and anapplicator pad (not shown). The applicator device 2070 includes a grip2040 including a first portion 2042 and a second portion 2044. The firstportion 2042 can define an interior space within which the reservoir2050 can be disposed. The second portion 2044 can be configured torotate and advance relative to the first portion 2042. For example, thesecond portion 2044 can be coupled to the first portion 2042 via athreaded connection. A first force concentrating component 2009A can bedisposed on a reservoir-facing surface of the second portion 2044 and/ora second force concentrating component 2009B can be disposed on areservoir-facing surface of the first portion 2042 (e.g., on a sidewallor a ramp or projection extending from the sidewall). In someembodiments, rotation of the second portion 2044 can cause the secondportion 2044 to advance toward the reservoir and apply pressure to thereservoir 2050 with the first force concentrating component 2009A untilthe reservoir 2050 breaks. In some embodiments, rotation of the secondportion 2044 can cause the second portion 2044 to advance toward thereservoir and/or advance the reservoir such that the reservoir 2050 isurged against the second force concentrating component 2009B until thereservoir 2050 breaks. In some embodiments, the second forceconcentrating component 2009B can be disposed such that the second forceconcentrating component 2009B will contact a shoulder of the reservoir2050 and break the reservoir 2050 at the shoulder. In some embodiments,an air vent (not shown) can be included to facilitate fluid travel fromthe reservoir 2050 toward the applicator pad (not shown).

In some embodiments, an applicator pad can be prepared (e.g., wetted) ina tray included in a kit prior to being applied to a target wound of asubject. For example, FIGS. 25A-25C are schematic illustrations of asequence of steps performed using a kit 2100. The kit 2100 can includeany of the systems used according to any of the methods describedherein. For example, the kit 2100 can include an applicator pad 2110 anda reservoir 2150 containing fluid. As shown in FIG. 25A, the kit 2100can include a tray 2101 housing the applicator pad 2110 and thereservoir 2150. The fluid in the reservoir 2150 can include a medicationand/or a medication activating agent such as saline. As shown in FIG.25A, the applicator pad 2110 can optionally include or be coupled toadhesive strips 2103 configured to attach the applicator pad 2110 toskin of a subject. As shown in FIG. 25B, the fluid can be transferredfrom the reservoir 2150 to the applicator pad 2110 to transfermedication to the applicator pad 2110 and/or to combine with drymedication predisposed in the applicator pad 2110. The reservoir 2150can be similar to any of the reservoirs described herein. Furthermore,the fluid can be transferred from the reservoir 2150 using any of theapplicator devices described herein. As shown in FIG. 25C, a backingportion 2118 (e.g., a bandage) can be coupled to the applicator pad 2110(e.g., via adhesive). The backing portion 2118 can include a convexdistal surface 2136 configured to be coupled to the applicator pad 2110to apply targeted and increased pressure to the wound via the applicatorpad 2110. The applicator pad 2110 can then be disposed in contact withthe wound with the backing portion 2118 being coupled to the skinsurrounding the wound. In some embodiments, the backing portion 2118 canbe removed after a predetermined period of time (e.g., four, five, six,or ten minutes).

In some embodiments, an applicator device such as any of the applicatordevices described herein can be included in the kit 2100 can used torelease the contents of the reservoir. The applicator device can then beused to apply the applicator pad 2110 to the wound and to apply pressureto the wound, or the applicator pad 2110 can optionally be separatedfrom the applicator device (e.g., in the tray 2101) and the applicatorpad 2110 can be applied to the wound and pressed against the wound usingfingers and/or a palm of the subject or caregiver. Optionally, thebacking portion 2118 can be applied to the applicator pad 2110 before orafter applying the applicator pad 2110 to the wound.

FIGS. 26A-26C are schematic illustrations of a sequence of stepsperformed using a kit 2200. The kit 2200 can include any of the systemsused according to any of the methods described herein. For example, thekit 2200 can include an applicator pad 2210 and a reservoir 2250containing fluid. As shown in FIG. 26A, the kit 2200 can include a tray2201 housing the applicator pad 2210 and the reservoir 2250. The fluidin the reservoir 2250 can include a medication and/or a medicationactivating agent such as saline. As shown in FIG. 26B, the fluid can betransferred from the reservoir 2250 to the applicator pad 2210 totransfer medication to the applicator pad 2210 and/or to combine withdry medication predisposed in the applicator pad 2210. The reservoir2250 can be similar to any of the reservoirs described herein.Furthermore, the fluid can be transferred from the reservoir 2250 usingany of the applicator devices described herein. As shown, for example,the kit 2200 can include a grip 2240 that can be disposed over at leasta portion (e.g., a neck portion or a half portion) of the reservoir 2250as shown in FIG. 26B and rotated away from a central axis of thereservoir 2250 such that a portion of the reservoir 2250 disposed withinthe grip 2240 is broken (e.g., separated from a remainder of thereservoir 2250 outside of the grip 2240) and fluid is released.

As shown in FIG. 26C, a backing portion 2118 (e.g., a bandage) can becoupled to the applicator pad 2210 (e.g., via adhesive). The backingportion 2218 can include a convex distal surface configured to becoupled to the applicator pad 2210 to apply targeted and increasedpressure to the wound via the applicator pad 2210. The applicator pad2210 can then be disposed in contact with the wound with the backingportion 2218 being coupled to the skin surrounding the wound. In someembodiments, the backing portion 2218 can be removed after apredetermined period of time (e.g., four, five, six, or ten minutes).

In some embodiments, an applicator device such as any of the applicatordevices described herein can be included in the kit 2200 can used torelease the contents of the reservoir. The applicator device can then beused to apply the applicator pad 2210 to the wound and to apply pressureto the wound, or the applicator pad 2210 can optionally be separatedfrom the applicator device (e.g., in the tray 2201) and the applicatorpad 2210 can be applied to the wound and pressed against the wound usingfingers and/or a palm of the subject or caregiver. Optionally, thebacking portion 2218 can be applied to the applicator pad 2210 before orafter applying the applicator pad 2210 to the wound.

While various embodiments have been described herein, textually and/orgraphically, it should be understood that they have been presented byway of example only, and not limitation. Likewise, it should beunderstood that the specific terminology used herein is for the purposeof describing particular embodiments and/or features or componentsthereof and is not intended to be limiting. Various modifications,changes, enhancements, and/or variations in form and/or detail may bemade without departing from the scope of the disclosure and/or withoutaltering the function and/or advantages thereof unless expressly statedotherwise. Functionally equivalent embodiments, implementations, and/ormethods, in addition to those enumerated herein, will be apparent tothose skilled in the art from the foregoing descriptions and areintended to fall within the scope of the disclosure.

Where schematics, embodiments, and/or implementations described aboveindicate certain components arranged and/or configured in certainorientations or positions, the arrangement of components may bemodified, adjusted, optimized, etc. The specific size and/or specificshape of the various components can be different from the embodimentsshown and/or can be otherwise modified, while still providing thefunctions as described herein. More specifically, the size and shape ofthe various components can be specifically selected for a desired orintended usage. Thus, it should be understood that the size, shape,and/or arrangement of the embodiments and/or components thereof can beadapted for a given use unless the context explicitly states otherwise.By way of example, in some implementations, a treatment device intendedto provide treatment to an adult user may have a first size and/orshape, while a treatment device intended to provide treatment to apediatric user may have a second size and/or shape smaller than thefirst size and/or shape. Moreover, the smaller size and/or shape of, forexample, a pediatric treatment device may result in certain componentsbeing moved, reoriented, and/or rearranged while maintaining the desiredfunction of the device.

Although various embodiments have been described as having particularcharacteristics, functions, components, elements, and/or features, otherembodiments are possible having any combination and/or sub-combinationof the characteristics, functions, components, elements, and/or featuresfrom any of the embodiments described herein, except mutually exclusivecombinations or when clearly stated otherwise. Moreover, unlessotherwise clearly indicated herein, any particular combination ofcomponents, functions, features, elements, etc. can be separated and/orsegregated into independent components, functions, features, elements,etc. or can integrated into a single or unitary component, function,feature, element, etc.

Where methods described above indicate certain events occurring incertain order, the ordering of certain events may be modified.Additionally, certain of the events may be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. While methods have been described as having particularsteps and/or combinations of steps, other methods are possible having acombination of any steps from any of methods described herein, exceptmutually exclusive combinations and/or unless the context clearly statesotherwise.

1-77. (canceled)
 78. A system, comprising: an applicator pad; a gripreleasably couplable to the applicator pad and configured to dispose theapplicator pad against a wound of a subject such that pressure can betransferred to the wound via the applicator pad to enhance hemostasis; areservoir configured to contain medication to be released to the woundvia the applicator pad; and a release mechanism coupled to the reservoirand configured to transition from a closed condition to an opencondition to allow medication to flow from the reservoir and to theapplicator pad via a fluid coupling in response to a pressure above athreshold pressure applied to the reservoir.
 79. The system of claim 78,wherein the reservoir is a first reservoir, and further comprising asecond reservoir included in the applicator pad.
 80. The system of claim78, wherein the applicator pad includes a pad retainer configured tomaintain the applicator pad in contact with the wound after the grip isdecoupled from the applicator pad.
 81. The system of claim 78, whereinthe grip includes a first portion and a second portion, the secondportion configured to be moved relative to the first portion to causeliquid to be released from the reservoir to the applicator pad.
 82. Thesystem of claim 78, wherein the medication includes an antifibrinolytic.83. The system of claim 78, wherein the medication includes at least oneof an antifibrinolytic, a vasoconstrictor, an antibiotic, ananti-infectant, or a steroid.
 84. The system of claim 78, wherein themedication is tranexamic acid (TXA).
 85. The system of claim 84, whereinthe applicator pad includes a material that is non-reactive with TXA.86. The system of claim 85, wherein the applicator pad includes a foamedpolymer.
 87. The system of claim 85, wherein the applicator pad includesa natural fiber.
 88. The system of claim 78, wherein the grip includes aplate disposed on a distal end of the grip and configured to apply adistributed, uniform force to the applicator pad when pressed toward thewound with a force orthogonal to the skin.
 89. The system of claim 78,wherein a sidewall portion of the grip is configured to be urged towardthe reservoir to transition the reservoir from a closed condition to anopen condition.
 90. The system of claim 78, wherein the applicator padincludes a backing having a convex distal surface such that theapplicator pad has a convex distal surface, the backing being more rigidthan a distal portion of the applicator pad coupled to the backing. 91.A system, comprising: an applicator pad; a grip releasably couplable tothe applicator pad and configured to dispose the applicator pad againsta wound of a subject such that pressure can be transferred to the woundvia the applicator pad to enhance hemostasis; a first reservoir includedin the applicator pad and configured to contain medication to bereleased to the wound via the applicator pad; a second reservoir; and afluid coupling configured such that liquid can flow from the secondreservoir to the applicator pad via the fluid coupling.
 92. The systemof claim 91, wherein the medication includes an antifibrinolytic. 93.The system of claim 91, wherein the medication includes at least one ofan antifibrinolytic, a vasoconstrictor, an antibiotic, ananti-infectant, or a steroid.
 94. The system of claim 91, wherein themedication is tranexamic acid (TXA).
 95. A system, comprising: anapplicator pad including a foamed polymer; a backing coupled to theapplicator pad, the backing being more rigid than the applicator pad; agrip releasably couplable to the applicator pad and configured todispose the applicator pad against a wound of a subject such thatpressure can be transferred to the wound via the applicator pad toenhance hemostasis; and a reservoir containing tranexamic acid (TXA) tobe released to the wound via the applicator pad.
 96. The system of claim95, wherein the backing has a convex distal surface.
 97. The system ofclaim 95, wherein the grip includes a first portion and a secondportion, the second portion configured to be moved relative to the firstportion to cause liquid to be released from the reservoir to theapplicator pad.
 98. The system of claim 97, wherein: the grip isconfigured to dispose the applicator pad against the wound of thesubject such that a force can be applied to the grip in a firstdirection to transfer the pressure to the wound via the applicator pad,the second portion is configured to be moved in a second directionrelative to the first portion to cause the liquid to be released fromthe reservoir of the applicator pad, and the first direction isdifferent from the second direction.
 99. A system, comprising: anapplicator pad; a grip releasably couplable to the applicator pad andconfigured to dispose the applicator pad against a wound of a subjectsuch that pressure can be transferred to the wound via the applicatorpad to enhance hemostasis, the grip including a housing defining aninterior; and a reservoir disposed within the interior and configured tocontain medication to be released to the wound via the applicator pad, aportion of the housing configured to be urged toward the reservoir totransition the reservoir from a closed condition to an open condition toallow medication to flow from the reservoir to the applicator pad. 100.The system of claim 99, wherein: the grip is configured to dispose theapplicator pad against the wound of the subject such that a force can beapplied to the grip in a first direction to transfer the pressure to thewound via the applicator pad, the portion of the housing is configuredto be moved in a second direction relative to the first portion totransition the reservoir from the closed condition to the opencondition, and the first direction is different from the seconddirection.
 101. The system of claim 99, wherein the portion of thehousing is a sidewall portion.
 102. The system of claim 99, wherein themedication includes an antifibrinolytic.
 103. The system of claim 99,wherein the medication includes at least one of an antifibrinolytic, avasoconstrictor, an antibiotic, an anti-infectant, or a steroid. 104.The system of claim 99, wherein the medication is tranexamic acid (TXA).